Approvals have been repeatedly delayed/rejected, and FDA regulatory policies are tightening?

544px;text-align:justify;white-space:normal;background-color:#FFFFFF;box-sizing:border-box ;overflow-wrap:break-word ;'>qpic.

In March, the U.
S.
Food and Drug Administration (FDA) unexpectedly postponed the approval review of 4 important drugs, and at the same time another 4 (upcoming) listing applications were rejected, which may indicate that the agency’s review strategy may take place Worrying changes.

The listing of blockbuster new drugs has been repeatedly delayed, and market forecasts have shrunk sharply

2018 Nian 12 Yue 18 , the State Drug Administration approved the enamel into Bo ( FibroGen ) Company Ai Ruizhuo ( Roxadustat , Rosa Division him) on the market for the treatment of patients undergoing dialysis because of chronic kidney disease (CKD ) Caused by anemia, this is the first time the drug has been approved for marketing in the world.
Roxastat was subsequently successfully approved for listing in Japan in September 2019 .

However, looking back at the process of rosarestat in the United States, it is indeed not smooth, and it seems that when the drug will be approved by the FDA, it seems inconclusive:

♦ 2019 Nian 12 Yue 23 days, into the enamel Bo announced to the FDA submission Rosa orlistat for the treatment of non-dialysis-dependent ( NDD ) and dialysis-dependent ( DD ) of anemia in patients with chronic kidney disease, a new drug application ( NDA ).

♦ 2020 Nian 2 Yue 11 days, into the enamel Bo announced, the FDA has completed his Secretary of Rosa NDA review, the FDA has "Prescription Drug User Fee Act" ( PDUFA date) is set at 2020 Nian 12 Yue 20 days.

♦ 2020 Nian 12 Yue 18 Ri, the FDA requested further clarification on clinical data analysis, in order to complete the Rocha department his NDA review.
Fabojin and its partner AstraZeneca ( AstraZeneca ) stated that they would cooperate with the FDA and agreed to submit other clarification analysis as soon as possible to assist in completing the product labeling discussion.
NDA will continue to regulatory review, the FDA has determined the new date was set for the 2021 Nian 3 Yue 20 days.

♦ 2021 Nian 3 Yue 1 day Bo into the enamel and AstraZeneca announced that the US FDA Cardiovascular and Renal Drugs Advisory Committee will convene Advisory Committee ( AdCom ) meetings to review his Secretary Rosa NDA .
However, the two companies did not receive the date of the advisory committee meeting confirmed by the FDA .

However, according to Bo into the enamel CEO Enrique • Kang Tenuo (Enrique Conterno) statement, the FDA 's idea occurred surprising change.
In a conference call, the FDA has told Fabojin on three different occasions that the agency does not plan to hold an advisory committee meeting on roxastat.

The discussion of the advisory committee (especially the discussion of innovative drugs like rosastat) is not surprising.
However, industry observers and investors were shocked because the FDA told the two companies three times that they would not hold such a meeting.
More importantly, the sudden change of position was made three weeks before the scheduled rosastat decision date.
It now appears that the FDA 's approval of rosastat has been postponed again.

If approved, roxastat will be the first oral HIF-PH inhibitor drug approved by the FDA , and will be used for erythropoietin injection therapies commonly used in the market such as Epogen/Procrit from Amgen and Johnson & Johnson.
Create a challenge.
For this reason, industry observers predict that rosastat will become a potential blockbuster drug.
It is predicted that by 2025 , the drug's annual sales may reach 3 billion to 3.
5 billion US dollars.
But now, due to the uncertainty brought by the advisory committee, industry analysts have reduced this forecast to US$ 719 million in 2025 on the basis of risk adjustments .

Roxastat was approved in China for the first time, and sales of the drug reached 29.
2 million US dollars in the fourth quarter of 2020 , higher than the 22.
7 million US dollars in the third quarter .
The drug was jointly developed by Fabojin and Astellas in Japan, and the approved trade name is Evrenzo .
It is expected that the European Union will make a regulatory decision on the drug by the end of this year.

In the category of HIF-PH inhibitors, Roxastat is not without competitors.
For example, two similar drugs have been approved for marketing in Japan, namely Vafseo ( vadadustat ) jointly developed by Akebia and Otsuka .
GlaxoSmithKline ( GlaxoSmithKline ) developed Duvroq ( daprodustat ).
However, in the Phase III PRO2TECT trial, vadadustat compared with Amgen's erythropoietin therapy Aranesp , the drug has an increased risk of heart disease, so the industry's expectations for the drug are low.

The review of new indications for 3 drugs has also been delayed

As a regulatory agency, the FDA’s decision to delay review or approval is understandable.
The problem is that recently, roxastat is not a case of delayed approval by the FDA , and the other three drugs have also suffered a similar fate.

5px;font-family:serif;box-sizing:border-box ;overflow-wrap:break-word ;">Nuplazid(pimavanserin)

3 Yue 3 days, Acadia Pharmaceuticals ( Acadia Pharmaceuticals ) has approved the company hopes to market the drug Nuplazid (pimavanserin) the first draft of the new label to obtain FDA review, on the contrary, the company has received a letter defect (deficiency letter) .
Since then, no more information has been received from the FDA .

Nuplazid is currently approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis, and the company has released phase III data from an impressive study of dementia-related psychosis .
Investors and analysts expect that the indication will be approved smoothly.
FDA last 7 Yue accepted the supplemental new drug application submitted Arcadia (sNDA) , said at the time, does not require consultants to review committee in 2021 Nian 4 Yue 3 to make a decision before May.
If approved this time, Nuplazid will be the first approved drug for the treatment of dementia-related psychosis.

And in 2 Yue 11 days, Arcadia also asked the FDA , if the agency still 3 Yue 3 label review date; 2 Yue 18 days, the FDA made a positive response.
3 Yue 3 Ri companies have received FDA 's letter, " identified deficiencies currently unable to discuss the requirements / commitments after the label and on the market.
"

FDA，，。FDA。

，FDA，，：，FDA。，FDA43。

Rinvoq(upadacitinib)

，（AbbVie）（adalimumab，）2023，JAK1Rinvoq(upadacitinib)。，FDA。

317，，FDARinvoq，《》，2021。

，FDA，Rinvoq。，FDA。

Keytruda(pembrolizumab)

329，Keytruda(pembrolizumab)，pembrolizumab（TNBC），（），（），FDA（PDUFA）2021329，，FDA（CRL）。

pCRⅢKEYNOTE-522（EFS），EFS。，FDA10-0KEYNOTE-522。2021。

75em;font-size:16px;background-color:#546CE8;letter-spacing:1.

5px;border-radius:10px;">：3FDA015px;font-weight:bold;">+Encequidar

0 25px;font-weight:bold;">Engligliflozin

0 35px;font-weight:bold;">Tanezumab

75em;color:#57AEFF;word-break:break-all;">

tesetaxel

On March 22, Odonate Therapeutics announced the termination of the development of a new oral taxane compound tesetaxel.
Odonate said that based on the FDA's feedback at the pre-NDA meeting, the clinical data of tesetaxel is unlikely to support the FDA's approval of the product.

qpic.

cn/mmbiz_png/YUyZ7AOL3onD7f6zuAgpSXdWmdYwO2zjGevxgTGCH4zMvOz6aicHMDmamLjoMBruibdPMRfcZXBpB4MNcbQqfia9A/640") 135 200 fill;border-width:20px 30px;'>

    

In March, the U.
S.
Food and Drug Administration (FDA) unexpectedly postponed the approval review of 4 important drugs, and at the same time another 4 (upcoming) listing applications were rejected, which may indicate that the agency’s review strategy may take place Worrying changes.

qpic.
cn/mmbiz_png/YUyZ7AOL3onD7f6zuAgpSXdWmdYwO2zjGevxgTGCH4zMvOz6aicHMDmamLjoMBruibdPMRfcZXBpB4MNcbQqfia9A/640") 135 200 fill;border-width:20px 30px;'>

    

In March, the U.
S.
Food and Drug Administration (FDA) unexpectedly postponed the approval review of 4 important drugs, and at the same time another 4 (upcoming) listing applications were rejected, which may indicate that the agency’s review strategy may take place Worrying changes.

qpic.
cn/mmbiz_png/YUyZ7AOL3onD7f6zuAgpSXdWmdYwO2zjGevxgTGCH4zMvOz6aicHMDmamLjoMBruibdPMRfcZXBpB4MNcbQqfia9A/640") 135 200 fill;border-width:20px 30px;'>

    

In March, the U.
S.
Food and Drug Administration (FDA) unexpectedly postponed the approval review of 4 important drugs, and at the same time another 4 (upcoming) listing applications were rejected, which may indicate that the agency’s review strategy may take place Worrying changes.

    

In March, the U.
S.
Food and Drug Administration (FDA) unexpectedly postponed the approval review of 4 important drugs, and at the same time another 4 (upcoming) listing applications were rejected, which may indicate that the agency’s review strategy may take place Worrying changes.

The listing of blockbuster new drugs has been repeatedly delayed, and market forecasts have shrunk sharply

The listing of blockbuster new drugs has been repeatedly delayed, and market forecasts have shrunk sharply

The listing of blockbuster new drugs has been repeatedly delayed, and market forecasts have shrunk sharply

The listing of blockbuster new drugs has been repeatedly delayed, and market forecasts have shrunk sharply

The listing of blockbuster new drugs has been repeatedly postponed, and market forecasts have shrunk significantly.

2018 Nian 12 Yue 18 , the State Drug Administration approved the enamel into Bo ( FibroGen ) Company Ai Ruizhuo ( Roxadustat , Rosa Division him) on the market for the treatment of patients undergoing dialysis because of chronic kidney disease (CKD ) Caused by anemia, this is the first time the drug has been approved for marketing in the world.
Roxastat was subsequently successfully approved for listing in Japan in September 2019 .

2018 Nian 12 Yue 18 , the State Drug Administration approved the enamel into Bo ( FibroGen ) Company Ai Ruizhuo ( Roxadustat , Rosa Division him) on the market for the treatment of patients undergoing dialysis because of chronic kidney disease (CKD ) Caused by anemia, this is the first time the drug has been approved for marketing in the world.
Roxastat was subsequently successfully approved for listing in Japan in September 2019 .

However, looking back at the process of rosarestat in the United States, it is indeed not smooth, and it seems that when the drug will be approved by the FDA, it seems inconclusive:

However, looking back at the process of rosarestat in the United States, it is indeed not smooth, and it seems that when the drug will be approved by the FDA, it seems inconclusive:

♦ 2019 Nian 12 Yue 23 days, into the enamel Bo announced to the FDA submission Rosa orlistat for the treatment of non-dialysis-dependent ( NDD ) and dialysis-dependent ( DD ) of anemia in patients with chronic kidney disease, a new drug application ( NDA ).

♦ 2019 Nian 12 Yue 23 days, into the enamel Bo announced to the FDA submission Rosa orlistat for the treatment of non-dialysis-dependent ( NDD ) and dialysis-dependent ( DD ) of anemia in patients with chronic kidney disease, a new drug application ( NDA ).

♦ 2020 Nian 2 Yue 11 days, into the enamel Bo announced, the FDA has completed his Secretary of Rosa NDA review, the FDA has "Prescription Drug User Fee Act" ( PDUFA date) is set at 2020 Nian 12 Yue 20 days.

♦ 2020 Nian 2 Yue 11 days, into the enamel Bo announced, the FDA has completed his Secretary of Rosa NDA review, the FDA has "Prescription Drug User Fee Act" ( PDUFA date) is set at 2020 Nian 12 Yue 20 days.

♦ 2020 Nian 12 Yue 18 Ri, the FDA requested further clarification on clinical data analysis, in order to complete the Rocha department his NDA review.
Fabojin and its partner AstraZeneca ( AstraZeneca ) stated that they would cooperate with the FDA and agreed to submit other clarification analysis as soon as possible to assist in completing the product labeling discussion.
NDA will continue to regulatory review, the FDA has determined the new date was set for the 2021 Nian 3 Yue 20 days.

2020 Nian 12 Yue 18 Ri, the FDA requested further clarification on clinical data analysis, in order to complete the Rocha department his NDA review.
Fabojin and its partner AstraZeneca ( AstraZeneca ) stated that they would cooperate with the FDA and agreed to submit other clarification analysis as soon as possible to assist in completing the product labeling discussion.
NDA will continue to regulatory review, the FDA has determined the new date was set for the 2021 Nian 3 Yue 20 days.

♦ 2021 Nian 3 Yue 1 day Bo into the enamel and AstraZeneca announced that the US FDA Cardiovascular and Renal Drugs Advisory Committee will convene Advisory Committee ( AdCom ) meetings to review his Secretary Rosa NDA .
However, the two companies did not receive the date of the advisory committee meeting confirmed by the FDA .

♦ 2021 Nian 3 Yue 1 day Bo into the enamel and AstraZeneca announced that the US FDA Cardiovascular and Renal Drugs Advisory Committee will convene Advisory Committee ( AdCom ) meetings to review his Secretary Rosa NDA .
However, the two companies did not receive the date of the advisory committee meeting confirmed by the FDA .

However, according to Bo into the enamel CEO Enrique • Kang Tenuo (Enrique Conterno) statement, the FDA 's idea occurred surprising change.
In a conference call, the FDA has told Fabojin on three different occasions that the agency does not plan to hold an advisory committee meeting on roxastat.

However, according to Bo into the enamel CEO Enrique • Kang Tenuo (Enrique Conterno) statement, the FDA 's idea occurred surprising change.
In a conference call, the FDA has told Fabojin on three different occasions that the agency does not plan to hold an advisory committee meeting on roxastat.

The discussion of the advisory committee (especially the discussion of innovative drugs like rosastat) is not surprising.
However, industry observers and investors were shocked because the FDA told the two companies three times that they would not hold such a meeting.
More importantly, the sudden change of position was made three weeks before the scheduled rosastat decision date.
It now appears that the FDA 's approval of rosastat has been postponed again.

The discussion of the advisory committee (especially the discussion of innovative drugs like rosastat) is not surprising.
However, industry observers and investors were shocked because the FDA told the two companies three times that they would not hold such a meeting.
More importantly, the sudden change of position was made three weeks before the scheduled rosastat decision date.
It now appears that the FDA 's approval of rosastat has been postponed again.

If approved, roxastat will be the first oral HIF-PH inhibitor drug approved by the FDA , and will be used for erythropoietin injection therapies commonly used in the market such as Epogen/Procrit from Amgen and Johnson & Johnson.
Create a challenge.
For this reason, industry observers predict that rosastat will become a potential blockbuster drug.
It is predicted that by 2025 , the drug's annual sales may reach 3 billion to 3.
5 billion US dollars.
But now, due to the uncertainty brought by the advisory committee, industry analysts have reduced this forecast to US$ 719 million in 2025 on the basis of risk adjustments .

If approved, roxastat will be the first oral HIF-PH inhibitor drug approved by the FDA , and will be used for erythropoietin injection therapies commonly used in the market such as Epogen/Procrit from Amgen and Johnson & Johnson.
Create a challenge.
For this reason, industry observers predict that rosastat will become a potential blockbuster drug.
It is predicted that by 2025 , the drug's annual sales may reach 3 billion to 3.
5 billion US dollars.
But now, due to the uncertainty brought by the advisory committee, industry analysts have reduced this forecast to US$ 719 million in 2025 on the basis of risk adjustments .

Roxastat was approved in China for the first time, and sales of the drug reached 29.
2 million US dollars in the fourth quarter of 2020 , higher than the 22.
7 million US dollars in the third quarter .
The drug was jointly developed by Fabojin and Astellas in Japan, and the approved trade name is Evrenzo .
It is expected that the European Union will make a regulatory decision on the drug by the end of this year.

Roxastat was approved in China for the first time, and sales of the drug reached 29.
2 million US dollars in the fourth quarter of 2020 , higher than the 22.
7 million US dollars in the third quarter .
The drug was jointly developed by Fabojin and Astellas in Japan, and the approved trade name is Evrenzo .
It is expected that the European Union will make a regulatory decision on the drug by the end of this year.

In the category of HIF-PH inhibitors, Roxastat is not without competitors.
For example, two similar drugs have been approved for marketing in Japan, namely Vafseo ( vadadustat ) jointly developed by Akebia and Otsuka .
GlaxoSmithKline ( GlaxoSmithKline ) developed Duvroq ( daprodustat ).
However, in the Phase III PRO2TECT trial, vadadustat compared with Amgen's erythropoietin therapy Aranesp , the drug has an increased risk of heart disease, so the industry's expectations for the drug are low.

In the category of HIF-PH inhibitors, Roxastat is not without competitors.
For example, two similar drugs have been approved for marketing in Japan, namely Vafseo ( vadadustat ) jointly developed by Akebia and Otsuka .
GlaxoSmithKline ( GlaxoSmithKline ) developed Duvroq ( daprodustat ).
However, in the Phase III PRO2TECT trial, vadadustat compared with Amgen's erythropoietin therapy Aranesp , the drug has an increased risk of heart disease, so the industry's expectations for the drug are low.

The review of new indications for 3 drugs has also been delayed

The review of new indications for 3 drugs has also been delayed

The review of new indications for 3 drugs has also been delayed

The review of new indications for 3 drugs has also been delayed

The review of new indications for 3 drugs was also delayed.
The review of new indications for 3 drugs was also delayed.
The review of new indications for 3 drugs was also delayed.

As a regulatory agency, the FDA’s decision to delay review or approval is understandable.
The problem is that recently, roxastat is not a case of delayed approval by the FDA , and the other three drugs have also suffered a similar fate.

As a regulatory agency, the FDA’s decision to delay review or approval is understandable.
The problem is that recently, roxastat is not a case of delayed approval by the FDA , and the other three drugs have also suffered a similar fate.

5px;font-family:serif;box-sizing:border-box ;overflow-wrap:break-word ;">Nuplazid(pimavanserin)

5px;font-family:serif;box-sizing:border-box ;overflow-wrap:break-word ;">Nuplazid(pimavanserin)5px;font-family:serif;box-sizing:border-box ;overflow-wrap:break-word ;"> Nuplazid(pimavanserin)5px;font-family:serif;box-sizing:border-box ;overflow-wrap:break-word ;"> Nuplazid(pimavanserin)

3 Yue 3 days, Acadia Pharmaceuticals ( Acadia Pharmaceuticals ) has approved the company hopes to market the drug Nuplazid (pimavanserin) the first draft of the new label to obtain FDA review, on the contrary, the company has received a letter defect (deficiency letter) .
Since then, no more information has been received from the FDA .

3 Yue 3 days, Acadia Pharmaceuticals ( Acadia Pharmaceuticals ) has approved the company hopes to market the drug Nuplazid (pimavanserin) the first draft of the new label to obtain FDA review, on the contrary, the company has received a letter defect (deficiency letter) .
Since then, no more information has been received from the FDA .

Nuplazid is currently approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis, and the company has released phase III data from an impressive study of dementia-related psychosis .
Investors and analysts expect that the indication will be approved smoothly.
FDA last 7 Yue accepted the supplemental new drug application submitted Arcadia (sNDA) , said at the time, does not require consultants to review committee in 2021 Nian 4 Yue 3 to make a decision before May.
If approved this time, Nuplazid will be the first approved drug for the treatment of dementia-related psychosis.

Nuplazid is currently approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis, and the company has released phase III data from an impressive study of dementia-related psychosis .
Investors and analysts expect that the indication will be approved smoothly.
FDA last 7 Yue accepted the supplemental new drug application submitted Arcadia (sNDA) , said at the time, does not require consultants to review committee in 2021 Nian 4 Yue 3 to make a decision before May.
If approved this time, Nuplazid will be the first approved drug for the treatment of dementia-related psychosis.

211，FDA，33；218，FDA。33FDA，“/。”

211，FDA，33；218，FDA。33FDA，“/。”

FDA，，。FDA。

FDA，，。FDA。

，FDA，，：，FDA。，FDA43。

，FDA，，：，FDA。，FDA43。

Rinvoq(upadacitinib)

Rinvoq(upadacitinib)Rinvoq(upadacitinib)Rinvoq(upadacitinib)

In addition, Abbvie ( AbbVie ) has been eager in the immunological blockbuster Humira ( adalimumab , adalimumab) in 2023 before patent expiration, the introduction of the next generation of alternative medicine JAK1 inhibitor Rinvoq (upadacitinib) .
However, AbbVie's efforts to expand the indications have encountered obstacles at the FDA .

In addition, Abbvie ( AbbVie ) has been eager in the immunological blockbuster Humira ( adalimumab , adalimumab) in 2023 before patent expiration, the introduction of the next generation of alternative medicine JAK1 inhibitor Rinvoq (upadacitinib) .
However, AbbVie's efforts to expand the indications have encountered obstacles at the FDA .

3 Yue 17 days, Abbvie announced, the FDA extended the Rinvoq review period the treatment of adult patients with active psoriatic arthritis supplementary new drug application, updated "Prescription Drug User Fee Act" Action Date has been extended for three months, to 2021 At the end of the second quarter of the year.

3 Yue 17 days, Abbvie announced, the FDA extended the Rinvoq review period the treatment of adult patients with active psoriatic arthritis supplementary new drug application, updated "Prescription Drug User Fee Act" Action Date has been extended for three months, to 2021 At the end of the second quarter of the year.

Prior to this, AbbVie also received an information request from the FDA requesting an updated assessment of the benefits and risks of Rinvoq in the treatment of psoriatic arthritis.
AbbVie responded to this request, and the FDA will need additional time to conduct a full review of the submitted content.

Prior to this, AbbVie also received an information request from the FDA requesting an updated assessment of the benefits and risks of Rinvoq in the treatment of psoriatic arthritis.
AbbVie responded to this request, and the FDA will need additional time to conduct a full review of the submitted content.

Keytruda (pembrolizumab)

Keytruda (pembrolizumab) Keytruda (pembrolizumab)

3 Yue 29 days, was originally Merck mention pay Keytruda (pembrolizumab) to add the date of approval of the Biologics License Application, the application involves pembrolizumab patients at high risk for early treatment of triple negative breast cancer (TNBC) and combination chemotherapy as neoadjuvant drugs ( preoperative) treatment, and then after the operation to continue as a single agent as an auxiliary (after surgery) treatment, FDA prescription Drug use fee Act case (PDUFA) date of March 29, 2021, but in the same day, Merck has received the FDA's complete Response letter (CRL).

3 Yue 29 days, was originally Merck mention 3 Yue 29 days, pay Keytruda (pembrolizumab) approval date of the Supplemental Biologics License Application, the application involves pembrolizumab patients at high risk for early treatment of triple negative breast cancer (TNBC) and combination chemotherapy As a neoadjuvant drug (preoperative) treatment, and then continue as a single drug as an adjuvant (postoperative) treatment after the operation, the FDA prescription drug usage fee method pembrolizumab case (PDUFA) date is March 29, 2021, but on the same day, Merck But received a complete response letter (CRL) from the FDA.

The application is based on the pCR data and the intermediate event-free survival (EFS) results of the Phase III KEYNOTE-522 trial, which is continuing to evaluate EFS.

Previously, the FDA Oncology Drug Advisory Committee voted 10-0 to require more data from the KEYNOTE-522 trial to pass the regulatory decision.
The next interim analysis will be conducted in the third quarter of 2021.

The application is based on the pCR data and the intermediate event-free survival (EFS) results of the Phase III KEYNOTE-522 trial, which is continuing to evaluate EFS.

0 25px;font-weight:bold;">Engligliflozin

0 35px;font-weight:bold;">Tanezumab

75em;color:#57AEFF;word-break:break-all;">

tesetaxel

On March 22, Odonate Therapeutics announced the termination of the development of a new oral taxane compound tesetaxel.
Odonate said that based on the FDA's feedback at the pre-NDA meeting, the clinical data of tesetaxel is unlikely to support the FDA's approval of the product.

75em;font-size:16px;background-color:#546CE8;letter-spacing:1.

5px;border-radius:10px;">Further reading: Project rejected by FDA in March0 15px;font-weight:bold;">Oral paclitaxel + Encequidar

0 25px;font-weight:bold;">Engligliflozin

0 35px;font-weight:bold;">Tanezumab

75em;color:#57AEFF;word-break:break-all;">

tesetaxel

On March 22, Odonate Therapeutics announced the termination of the development of a new oral taxane compound tesetaxel.
Odonate said that based on the FDA's feedback at the pre-NDA meeting, the clinical data of tesetaxel is unlikely to support the FDA's approval of the product.

75em;font-size:16px;background-color:#546CE8;letter-spacing:1.
5px;border-radius:10px;">Further reading: Project rejected by FDA in March75em;font-size:16px;background-color:#546CE8;letter-spacing:1.
5px;border-radius:10px;">Further reading: Project rejected by FDA in March0 15px;font-weight:bold;">Oral paclitaxel + Encequidar
75em;letter-spacing:1.
5px;font-size:14px;">

On March 1, Athenex issued an announcement stating that the FDA had issued a complete response letter (CRL) for the company's new drug listing application (NDA) for the company's metastatic breast cancer therapy, oral paclitaxel + Encequidar, and rejected the listing of the therapy.
According to the announcement, the main reason for the refusal was the FDA’s concern that compared with intravenous paclitaxel, oral paclitaxel may increase the safety risk of neutropenia-related sequelae.

0 25px;font-weight:bold;">Engligliflozin
75em;letter-spacing:1.
5px;font-size:14px;">

On March 20, Eli Lilly announced that it had received a complete response letter from the FDA.
The FDA refused to approve the supplementary application of its SGLT2 inhibitor, Enpagliflozin, for the treatment of type 1 diabetes.

0 35px;font-weight:bold;">Tanezumab
75em;letter-spacing:1.
5px;font-size:14px;">

On March 24-25, the FDA expert committee held a meeting to review Pfizer’s osteoarthritis pain drug NGF antibody Tanezumab.
As a result, only one expert supported the approval, and the remaining 19 experts refused to approve it.

75em;color:#57AEFF;word-break:break-all;">

tesetaxel

On March 22, Odonate Therapeutics announced the termination of the development of a new oral taxane compound tesetaxel.
Odonate said that based on the FDA's feedback at the pre-NDA meeting, the clinical data of tesetaxel is unlikely to support the FDA's approval of the product.

0 15px;font-weight:bold;">Oral paclitaxel + Encequidar
75em;letter-spacing:1.
5px;font-size:14px;">

On March 1, Athenex issued an announcement stating that the FDA had issued a complete response letter (CRL) for the company's new drug listing application (NDA) for the company's metastatic breast cancer therapy, oral paclitaxel + Encequidar, and rejected the listing of the therapy.
According to the announcement, the main reason for the refusal was the FDA’s concern that compared with intravenous paclitaxel, oral paclitaxel may increase the safety risk of neutropenia-related sequelae.

0 15px;font-weight:bold;">Oral paclitaxel + Encequidar0 115px;font-weight:bold;">Oral paclitaxel + Encequidar75em;letter-spacing:1.
5px;font-size:14px;">

On March 1, Athenex issued an announcement stating that the FDA had issued a complete response letter (CRL) for the company's new drug listing application (NDA) for the company's metastatic breast cancer therapy, oral paclitaxel + Encequidar, and rejected the listing of the therapy.
According to the announcement, the main reason for the refusal was the FDA’s concern that compared with intravenous paclitaxel, oral paclitaxel may increase the safety risk of neutropenia-related sequelae.

On March 1, Athenex issued an announcement stating that the FDA had issued a complete response letter (CRL) for the company's new drug listing application (NDA) for the company's metastatic breast cancer therapy, oral paclitaxel + Encequidar, and rejected the listing of the therapy.
According to the announcement, the main reason for the refusal was the FDA’s concern that compared with intravenous paclitaxel, oral paclitaxel may increase the safety risk of neutropenia-related sequelae.

0 25px;font-weight:bold;">Engligliflozin
75em;letter-spacing:1.
5px;font-size:14px;">

On March 20, Eli Lilly announced that it had received a complete response letter from the FDA.
The FDA refused to approve the supplementary application of its SGLT2 inhibitor, Enpagliflozin, for the treatment of type 1 diabetes.

0 25px;font-weight:bold;">Engligliflozin0 225px;font-weight:bold;">Engligliflozin75em;letter-spacing:1.
5px;font-size:14px;">

On March 20, Eli Lilly announced that it had received a complete response letter from the FDA.
The FDA refused to approve the supplementary application of its SGLT2 inhibitor, Enpagliflozin, for the treatment of type 1 diabetes.

On March 20, Eli Lilly announced that it had received a complete response letter from the FDA.
The FDA refused to approve the supplementary application of its SGLT2 inhibitor, Enpagliflozin, for the treatment of type 1 diabetes.

0 35px;font-weight:bold;">Tanezumab
75em;letter-spacing:1.
5px;font-size:14px;">

On March 24-25, the FDA expert committee held a meeting to review Pfizer’s osteoarthritis pain drug NGF antibody Tanezumab.
As a result, only one expert supported the approval, and the remaining 19 experts refused to approve it.

75em;color:#57AEFF;word-break:break-all;">

tesetaxel

On March 22, Odonate Therapeutics announced the termination of the development of a new oral taxane compound tesetaxel.
Odonate said that based on the FDA's feedback at the pre-NDA meeting, the clinical data of tesetaxel is unlikely to support the FDA's approval of the product.

0 35px;font-weight:bold;">Tanezumab0 335px;font-weight:bold;">Tanezumab75em;letter-spacing:1.
5px;font-size:14px;">

On March 24-25, the FDA expert committee held a meeting to review Pfizer’s osteoarthritis pain drug NGF antibody Tanezumab.
As a result, only one expert supported the approval, and the remaining 19 experts refused to approve it.

75em;color:#57AEFF;word-break:break-all;">

tesetaxel

On March 22, Odonate Therapeutics announced the termination of the development of a new oral taxane compound tesetaxel.
Odonate said that based on the FDA's feedback at the pre-NDA meeting, the clinical data of tesetaxel is unlikely to support the FDA's approval of the product.

On March 24-25, the FDA expert committee held a meeting to review Pfizer’s osteoarthritis pain drug NGF antibody Tanezumab.
As a result, only one expert supported the approval, and the remaining 19 experts refused to approve it.

75em;color:#57AEFF;word-break:break-all;">

tesetaxel

On March 22, Odonate Therapeutics announced the termination of the development of a new oral taxane compound tesetaxel.
Odonate said that based on the FDA's feedback at the pre-NDA meeting, the clinical data of tesetaxel is unlikely to support the FDA's approval of the product.

75em;color:#57AEFF;word-break:break-all;">

tesetaxel

On March 22, Odonate Therapeutics announced the termination of the development of a new oral taxane compound tesetaxel.
Odonate said that based on the FDA's feedback at the pre-NDA meeting, the clinical data of tesetaxel is unlikely to support the FDA's approval of the product.

75em;color:#57AEFF;word-break:break-all;">

tesetaxel

On March 22, Odonate Therapeutics announced the termination of the development of a new oral taxane compound tesetaxel.
Odonate said that based on the FDA's feedback at the pre-NDA meeting, the clinical data of tesetaxel is unlikely to support the FDA's approval of the product.

75em;color:#57AEFF;word-break:break-all;">

tesetaxel

On March 22, Odonate Therapeutics announced the termination of the development of a new oral taxane compound tesetaxel.
Odonate said that based on the FDA's feedback at the pre-NDA meeting, the clinical data of tesetaxel is unlikely to support the FDA's approval of the product.

tesetaxel

tesetaxel tesetaxel tesetaxel

On March 22, Odonate Therapeutics announced the termination of the development of a new oral taxane compound tesetaxel.
Odonate said that based on the FDA's feedback at the pre-NDA meeting, the clinical data of tesetaxel is unlikely to support the FDA's approval of the product.

544px;text-align:justify;white-space:normal;background-color:#FFFFFF;box-sizing:border-box ;overflow-wrap:break-word ;'>

FDA regulation begins to tighten?

，FDA4。3，4PD-(L)14，FDA4（ODAC），3PD-（L）1。

“FDA？”。

，FDA，，202053，，201859。，FDA，，，，，。

，，FDA·(Janet Woodcock)FDA。·。·“”“”，FDA。FDA。

FDA？，Rinvoq“FDA”。

FDA？

FDA？

FDA？

FDA？

FDA？FDA？

，FDA4。3，4PD-(L)14，FDA4（ODAC），3PD-（L）1。

，FDA44。3，4PD-(L)14，FDA4（ODAC），3PD-（L）1。

“FDA？”。

“FDA？”。

，FDA，，202053，，201859。，FDA，，，，，。

，FDA，，202053，，201859。，FDA，，，，，。

，，FDA·(Janet Woodcock)FDA。·。·“”“”，FDA。FDA。

，，FDA·(Janet Woodcock)FDA。·。·“”“”，FDA。FDA。

FDA？，Rinvoq“FDA”。

FDA？，Rinvoq“FDA”。