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What new drugs are expected to be approved by the US FDA in March this year?

 Last Update: 2022-04-30
 Source: Internet
 Author: User

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Last year, the FDA approved 50 new drugs
.

In the first quarter of 2022, the FDA has continued to approve seven new drugs and expects to make five more review decisions by the end of this month , as detailed in the table below

5 more review decisions to be made by the end of the month

1.
New drug name: relatlimab + nivolumab fixed-dose combination therapy (FDC)

R & D company: Bristol-Myers Squibb

Disease treated: Unresectable or metastatic melanoma

The current number one PDUFA date is Bristol-Myers Squibb's relatlimab + nivolumab fixed-dose combination therapy (FDC) for the treatment of unresectable or metastatic melanoma
.

This Biologics License Application (BLA) is supported by positive Phase 3 safety and efficacy data showing that this combination treatment modality is statistically significant relative to anti-PD-1 antibody monotherapy in metastatic melanoma Significance and clinically meaningful progression-free survival benefit

This combination treatment modality demonstrated a statistically and clinically meaningful progression-free survival benefit relative to anti-PD-1 antibody monotherapy in metastatic melanoma

R&D Company: Marinus Pharmaceuticals

Treating Disease: Seizures Associated with CDKL5 Deficiency

Marinus Pharmaceuticals' ganaxolone oral suspension is a gamma-aminobutyric acid (GABAA) receptor allosteric modulator
.

In July 2021, Marinus filed a New Drug Application (NDA) in the U.

The drug, which is expected to be launched in June 2022, has the potential to address unmet needs in multiple rare epilepsy

R&D Company: Mezzion Pharma

Treating Disease: Single Ventricular Heart Disease

Mezzion Pharma's udenafil is a long-acting, selective, oral phosphodiesterase type 5 (PDE5) inhibitor indicated for the treatment of patients 12 years of age and older with single ventricular heart disease (SVHD) who have received Fontan's (Fontan) exercise capacity in patients undergoing surgery
.

Although Fontan's surgery creates a stable circulation and the patient's single ventricle can pump blood into the body, due to decreased exercise capacity, the patient is at risk of hospitalization and cardiac death in the two or three decades after the Fontan's surgery is completed.

If approved by the FDA on or before March 26, 2022, udenafil would be potentially the first therapy approved for this rare pediatric disease

R&D Company: Akebia Therapeutics/Otsuka Pharmaceutical

Treatment disease: renal anemia

Akebia and Otsuka's vadadustat, a potential "first-in-class" hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, is used orally for the treatment of chronic kidney disease (CKD)-induced Anemia
.

The drug is already on the market in Japan

Phase 3 clinical results showed that safety and efficacy endpoints were met in the dialysis-dependent population
.

5.
New drug name: efbemalenograstim alfa

R & D company: Yiyi Biological

Treating the disease: Chemotherapy-induced neutropenia

Finally, Yiyi Bio's efbemalenograstim alfa is a fusion protein composed of a dimeric recombinant human granulocyte colony-stimulating factor (rhG-CSF) and a human IgG2-Fc fragment, and an FDA decision is expected on March 30, 2022
.
Based on safety and efficacy data from two global Phase 3 clinical trials, the company submitted a BLA in March 2021 for chemotherapy-induced neutropenia
.
The drug's new drug marketing application (MAA) in the EU is also under review
.
Last month, China's National Medical Products Administration (NMPA) accepted the drug's marketing application in China
.
Due to its unique structure, if approved, it would offer a long-acting treatment option to replace current pegylated G-CSF modalities
.

It will provide a long-acting treatment option to replace the current pegylated G-CSF treatment modality
.

Expected US New Drug Approvals in March

Last year, the US FDA approved 50 new drugs.
For the first quarter of 2022, it has so far approved seven and is expecting to make decisions on five more by the end of this month .

is expecting to make decisions on five more by the end of this month

( By WuXi AppTec content team.
Click the image to view at full size )

1.
Drug: Relatlimab + nivolumab (fixed dose combination)

Company: Bristol Myers Squibb

Indication(s): Unresectable or metastatic melanoma

The first FDA decision to be made in March is on Bristol Myers Squibb's relatlimab plus nivolumab fixed-dose combination (FDC), seeking marketing approval for the treatment of unresectable or metastatic melanoma.
The BLA filing was supported by positive phase III safety and efficacy data which showed statistically significant and clinically meaningful progression-free survival benefit of the FDC over anti-PD-1 monotherapy in metastatic melanoma.
The FDA is expected to make a decision by March 19, 2022.
Upon approval, this could be the first-in -class FDC therapy of anti-LAG3 mAb plus anti-PD-1 mAb.

The BLA filing was supported by positive phase III safety and efficacy data which showed statistically significant and clinically meaningful progression-free survival benefit of the FDC over anti-PD-1 monotherapy in metastatic melanoma.
this could be the first-in-class FDC therapy of anti-LAG3 mAb plus anti-PD-1 mAb.

2.
Drug: ganaxolone

Company: Marinus Pharmaceuticals

Indication(s): Seizures associated with CDKL5 deficiency disorder

This is closely followed by Marinus' oral suspension formulation of ganaxolone, a positive allosteric GABAA receptor modulator.
An NDA was submitted in the US in July 2021 for the treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder, a rare, genetic epilepsy with no disease-specific treatments approved hitherto.
The company expects PDUFA action date to be on March 20, 2022 for the oral formulation, with anticipated launch in June 2022.
The drug has potential for expansion to complimentary clinical indications to address unmet needs in multiple rare epilepsies.

The drug has potential for expansion to complimentary clinical indications to address unmet needs in multiple rare epilepsies.

3.
Drug: udenafil

Company: Mezzion Pharma

Indication(s): Single ventricle heart disease

Mezzion's udenafil is a long-acting, selective, oral phosphodiesterase-5 (PDE5) inhibitor, awaiting US approval as a therapeutic to improve the exercise capacity of patients 12 years of age and older with single ventricle heart disease (SVHD) who have undergone the Fontan operation.
While the Fontan procedure creates a stable circulation to allow the single ventricle to pump blood to the body, the risk of hospitalization and cardiac death increases in the second and third decades after Fontan completion, due to a decline in exercise capacity.
A late cycle review meeting was held with the FDA in February 2022 to explain the data submitted.
If approved by the FDA on or before the PDUFA date of March 26, 2022, udenafil would potentially be the first approved therapy for this rare pediatric disease population.

udenafil would potentially be the first approved therapy for this rare pediatric disease population.

4.
Drug: vadadustat

Company: Akebia Therapeutics/Otsuka Pharmaceutical

Indication(s): Anemia due to chronic kidney disease

The next in line to be reviewed by the FDA is Akebia's vadadustat, a potential first-in-class hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor for the oral treatment of anemia due to chronic kidney disease (CKD).
The drug is already marketed in Japan for this setting.
Phase III results indicated both safety and efficacy endpoints were met from the dialysis-dependent population.
The PDUFA date of vadadustat is March 29, 2022.

Phase III results indicated both safety and efficacy endpoints were met from the dialysis-dependent population.

5.
Drug: efbemalenograstim alfa

Company: Evive Biotech

Indication(s): Chemotherapy-induced neutropenia

Finally, Evive's efbemalenograstim alfa, a dimeric recombinant human granulocyte colony stimulating factor (rhG-CSF)-fc fusion protein, is expecting FDA approval decision on March 30, 2022.
The company submitted a BLA in March 2021 for the drug for chemotherapy-induced neutropenia, based on the positive phase III safety and efficacy data from two global trials.
An MAA is also under review in the EU.
Last month, the NMPA accepted marketing application of the drug in China.
Owing to its unique structure, it would present a long-acting alternative to the current standard of care pegylated G-CSF treatments.

Owing to its unique structure, it would present a long-acting alternative to the current standard of care pegylated G-CSF treatments.

References:

[1] New Drugs at FDA: CDER's New Molecular Entities and New Therapeutic Biological Products.
Retrieved March 11, 2022 from, https:// -cders-new-molecular-entities-and-new-therapeutic-biological-products

[2] Corporate Presentation of Marinus.
Retrieved March 11, 2022 from, https://s21.
q4cdn.
com/104148044/files/doc_presentations/2022/Bristol-Myers-Squibb-JPM-2022-Presentation.
pdf

[3] Marinus PharmaceuticalsSubmits New Drug Application (NDA) to FDA for Ganaxolone for the Treatment of Seizures Associated with CDKL5 Deficiency Disorder and Provides Pipeline Update.
Retrieved March 11, 2022 from, https://ir.
marinuspharma.
com/news/news -details/2021/Marinus-Pharmaceuticals-Submits-New-Drug-Application-NDA-to-FDA-for-Ganaxolone-for-the-Treatment-of-Seizures-Associated-with-CDKL5-Deficiency-Disorder-and-Provides -Pipeline-Update/default.
aspx

[4] Corporate Presentation of Marinus.
Retrieved March 11, 2022 from, https://s25.
q4cdn.
com/443656056/files/doc_downloads/2021/12/Corporate-Deck-December-FINAL.
pdf

[5] Mezzion's New DrugApplication ("NDA") for its Orphan Drug Udenafil for the Treatment of Single Ventricle Heart Disease ("SVHD") has been Accepted for Filing by the FDA.
Retrieved March 11, 2022 from, https://www.
prnewswire.
com/news-releases/mezzions-new-drug-application-nda-for-its-orphan-drug-udenafil-for-the-treatment-of-single-ventricle-heart-disease-svhd-has-been- accepted-for-filing-by-the-fda-301299410.
html

[6] Late-Cycle review Meeting Notice.
Retrieved March 11, 2022 from, https:// Late-Cycle review Meeting Notice.
Retrieved March 11, 2022 from, https:// [7] Akebia Therapeutics Reports Fourth Quarter and Full-Year 2021 Financial Results and Recent Business Highlights.
Retrieved March 11, 2022 from, https://ir.
akebia.
com/news-releases/news-release-details/akebia-therapeutics -reports-fourth-quarter-and-full-year-2021

[7] Akebia Therapeutics Reports Fourth Quarter and Full-Year 2021 Financial Results and Recent Business Highlights.
Retrieved March 11, 2022 from, https://ir.
akebia.
com/news-releases/news-release-details/akebia-therapeutics -reports-fourth-quarter-and-full-year-2021

[8] BETTERING THE LIVES OF PEOPLEIMPACTED BY KIDNEY DISEASE.
Retrieved March 11, 2022 from, https://ir.
akebia.
com/static-files/7bb8acb3-1543-4ce5-9154-37ccb4157671

[9] Update on US regulatory review of roxadustat in anaemia of chronic kidney disease.
Retrieved March 11, 2022 from, https:// review-of-roxadustat.
html

[10] Evive Biotech Submits Biologics License Application to US FDA for Ryzneuta(TM).
Retrieved March 11, 2022 from, https:// -to-us-fda-for-ryzneutatm-301259250.
html

[11] The European Medicines Agency officially accepted the marketing authorization application of Yiyi Biologics Ryzneuta™
.
RetrievedMarch 11, 2022 from, https:// The European Medicines Agency officially accepted the marketing authorization application of Yiyi Biologics Ryzneuta™
.
RetrievedMarch 11, 2022 from, https:// [12] The listing application of F-627 was officially accepted by the State Food and Drug Administration
.
Retrieved March 11, 2022 from, https:// The listing application of F-627 was officially accepted by the State Food and Drug Administration
.
Retrieved March 11, 2022 from, https://

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