Benzinga | Dec 21, 2021 09:05AM EST

Amgen's Otezla Wins FDA Approval For Psoriasis, Regardless Of Severity Level

The FDA has approved Amgen Inc's (NASDAQ:AMGN) Otezla (apremilast) to treat adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy.

* With this expanded indication, Otezla is now the first and only oral treatment approved in adult patients with plaque psoriasis across all severities, including mild, moderate, and severe.

* Related: AstraZeneca - Amgen's Tezspire Biologic Scores FDA Approval For Severe Asthma

* The FDA approval is based on Phase 3 ADVANCE trial data. Five times as many adults receiving oral Otezla 30 achieved the primary endpoint of Static Physician's Global Assessment response at week 16 compared to placebo (21.6% versus 4.1%).

* Otezla is approved for three indications in the U.S.

* Related content: Benzinga's Full FDA Calendar.

* Price Action: AMGN shares closed at $219.99 on Monday.