Amgen Reports the US FDA’s Acceptance of sNDA for Review of Otezla (apremilast) to Treat Mild-To-Moderate Plaque Psoriasis

May 6, 2021 Auto Bot Acceptance, Amgen, FDA, Otezla, Plaque Psoriasis, regulatory, sNDA 0

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

Click here to­ read full press release/ article | Ref: PRNewswire | Image: Amgen

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