THOUSAND OAKS (dpa-AFX) - Amgen (AMGN) announced the FDA has accepted for review the supplemental New Drug Application for Otezla for the treatment of adults with mild-to-moderate plaque psoriasis who are candidates for phototherapy or systemic therapy. The PDUFA action date is December 19, 2021.
David Reese, executive vice president of Research and Development at Amgen, said: 'The FDA's acceptance of this sNDA for Otezla is a significant milestone toward achieving our goal of potentially providing the first and only oral treatment option for the underserved mild-to-moderate patient population.'
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