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

The FDA has approved Amgen Inc's 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.