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▎ WuXi AppTec content team editor December 20, 2021, Amgen announced that the US FDA has expanded the indications of Otezla (apremilast) to treat plaque psoriasis suitable for phototherapy or systemic therapy Sick adult patients
.
The press release notes that this also makes Otezla the first oral treatment approved for use in adults with plaque psoriasis of all severity (including mild, moderate and severe)
.
Psoriasis is a chronic inflammatory skin disease whose symptoms include red patches covered with silver scales, dryness, chapped, bleeding, and thickened, sunken, or raised nails
.
For patients with more severe symptoms, psoriasis has a major impact on their lives
.
According to statistics released by the press release, psoriasis affects nearly 3% of the world's population, with 125 million patients worldwide
.
Although drug development in this field has made a lot of progress in the past 10 years, patient survey data shows that 30% of psoriasis patients cannot receive adequate treatment
.
Otezla is an oral selective phosphodiesterase 4 (PDE4) inhibitor
.
Inhibition of PDE4 leads to an increase in intracellular cAMP levels, and researchers believe that it can indirectly regulate the production of inflammatory mediators
.
The drug has been approved by the US FDA for 3 indications-the treatment of patients with moderate to severe plaque psoriasis suitable for phototherapy or systemic therapy; adult patients with active psoriatic arthritis; and Behcet's disease related Adult patients with oral ulcers
.
The FDA approval is based on the positive results of a phase 3 clinical trial
.
The trial reached its primary endpoint at week 16.
Among adult patients with mild to moderate plaque psoriasis, patients who received 30 mg Otezla twice daily (n=297) reached the static physician overall assessment (sPGA) ) The number of people who responded was 5 times (21.
6% VS.
4.
1%, p<0.
0001) of the placebo group (n=298), which was statistically significant
.
In addition, compared with placebo, the Otezla group also showed statistically significant improvements in key symptoms at week 16, such as NRS response to systemic pruritus (43.
2% VS.
18.
6%) and difficulty assessed by the Scalp Doctor’s Global Assessment (ScPGA) The scalp response to the treatment area improved (44% VS.
16.
6%)
.
In addition, improvement in sPGA response, NRS and ScPGA response of whole body pruritus was observed in the second week of treatment, and the therapeutic effect was maintained until the 32nd week
.
In terms of safety, the adverse events observed in the trial are consistent with the known safety characteristics of Otezla
.
The most common adverse events in the Otezla group were diarrhea, headache, nausea and nasopharyngitis
.
"Plaque psoriasis can bring a significant burden to the lives of patients, regardless of the severity of the skin involvement
.
Local therapy may not be able to repeatedly treat patients with mild to moderate plaque psoriasis, especially those who are difficult to treat.
Areas, such as the scalp, still have a large number of unmet needs
.
" Dr.
David M.
Reese, Executive Vice President of Amgen R&D, said, "With the expansion of Otezla indications, patients with all disease severity levels now have a new type of oral Systemic treatment options
.
"Reference: [1] FDA Approves Otezla (Apremilast) For The Treatment Of Adult Patients With Plaque Psoriasis, Regardless Of Severity Level.
Retrieved December 21, 2021, from https:// -approves-otezla-apremilast-for-the-treatment-of-adult-patients-with-plaque-psoriasis-regardless-of-severity-level-301448542.
html Disclaimer: WuXi AppTec's content team focuses on introducing global biomedical health Research progress
.
This article is for the purpose of information exchange only.
The opinions in the article do not represent WuXi AppTec’s position, nor does it mean that WuXi AppTec supports or opposes the opinions
in the
article .
This article is not a treatment plan recommendation
.
If you need treatment plan guidance, please go to a regular hospital See a doctor
.
.
The press release notes that this also makes Otezla the first oral treatment approved for use in adults with plaque psoriasis of all severity (including mild, moderate and severe)
.
Psoriasis is a chronic inflammatory skin disease whose symptoms include red patches covered with silver scales, dryness, chapped, bleeding, and thickened, sunken, or raised nails
.
For patients with more severe symptoms, psoriasis has a major impact on their lives
.
According to statistics released by the press release, psoriasis affects nearly 3% of the world's population, with 125 million patients worldwide
.
Although drug development in this field has made a lot of progress in the past 10 years, patient survey data shows that 30% of psoriasis patients cannot receive adequate treatment
.
Otezla is an oral selective phosphodiesterase 4 (PDE4) inhibitor
.
Inhibition of PDE4 leads to an increase in intracellular cAMP levels, and researchers believe that it can indirectly regulate the production of inflammatory mediators
.
The drug has been approved by the US FDA for 3 indications-the treatment of patients with moderate to severe plaque psoriasis suitable for phototherapy or systemic therapy; adult patients with active psoriatic arthritis; and Behcet's disease related Adult patients with oral ulcers
.
The FDA approval is based on the positive results of a phase 3 clinical trial
.
The trial reached its primary endpoint at week 16.
Among adult patients with mild to moderate plaque psoriasis, patients who received 30 mg Otezla twice daily (n=297) reached the static physician overall assessment (sPGA) ) The number of people who responded was 5 times (21.
6% VS.
4.
1%, p<0.
0001) of the placebo group (n=298), which was statistically significant
.
In addition, compared with placebo, the Otezla group also showed statistically significant improvements in key symptoms at week 16, such as NRS response to systemic pruritus (43.
2% VS.
18.
6%) and difficulty assessed by the Scalp Doctor’s Global Assessment (ScPGA) The scalp response to the treatment area improved (44% VS.
16.
6%)
.
In addition, improvement in sPGA response, NRS and ScPGA response of whole body pruritus was observed in the second week of treatment, and the therapeutic effect was maintained until the 32nd week
.
In terms of safety, the adverse events observed in the trial are consistent with the known safety characteristics of Otezla
.
The most common adverse events in the Otezla group were diarrhea, headache, nausea and nasopharyngitis
.
"Plaque psoriasis can bring a significant burden to the lives of patients, regardless of the severity of the skin involvement
.
Local therapy may not be able to repeatedly treat patients with mild to moderate plaque psoriasis, especially those who are difficult to treat.
Areas, such as the scalp, still have a large number of unmet needs
.
" Dr.
David M.
Reese, Executive Vice President of Amgen R&D, said, "With the expansion of Otezla indications, patients with all disease severity levels now have a new type of oral Systemic treatment options
.
"Reference: [1] FDA Approves Otezla (Apremilast) For The Treatment Of Adult Patients With Plaque Psoriasis, Regardless Of Severity Level.
Retrieved December 21, 2021, from https:// -approves-otezla-apremilast-for-the-treatment-of-adult-patients-with-plaque-psoriasis-regardless-of-severity-level-301448542.
html Disclaimer: WuXi AppTec's content team focuses on introducing global biomedical health Research progress
.
This article is for the purpose of information exchange only.
The opinions in the article do not represent WuXi AppTec’s position, nor does it mean that WuXi AppTec supports or opposes the opinions
in the
article .
This article is not a treatment plan recommendation
.
If you need treatment plan guidance, please go to a regular hospital See a doctor
.
