Shots:

• The acceptance is based on a P-III ADVANCE trial assessing the efficacy of Otezla (30 mg- bid) vs PBO in 595 patients in a ratio (1:1) with mild-to-moderate plaque psoriasis for the first 16wks. All patients then received Otezla during an OLE phase through week 32.
• Results: @16wks.- improvement in its 1EPs of sPGA score; achieve 2EPs i.e- 75% improvement in BSA- change in PASI score- clinical improvements were maintained @32wks. The anticipated PDUFA date is Dec 19- 2021
• Otezla is a selective PDE4 inhibitor and is approved for the mod. to sev. plaque psoriasis who are candidates for phototherapy or systemic therapy- active PsA- and oral ulcers associated with Behçet’s Disease

  Ref: PRNewswire | Image: Amgen