Posted by Michael Wonder on 05 May 2021
FDA accepts Amgen's supplemental new drug application for Otezla (apremilast) for adults with mild to moderate plaque psoriasis
5 May 2021 - Acceptance based on data from Phase 3 ADVANCE trial, demonstrating clinically meaningful improvements through week 32.
Amgen today announced that the U.S. FDA has accepted for review the supplemental new drug application for Otezla (apremilast) for the treatment of adults with mild to moderate plaque psoriasis who are candidates for phototherapy or systemic therapy.
The FDA has set a Prescription Drug User Fee Act action date of 19 December 2021.
