Posted by Michael Wonder on 29 Nov 2021
Bristol Myers Squibb’s applications for deucravacitinib for the treatment of moderate to severe plaque psoriasis accepted by U.S. Food and Drug Administration and validated by European Medicines Agency
29 November 2021 - Applications supported by positive results from the pivotal Phase 3 POETYK-PSO clinical trial program demonstrating superior efficacy of deucravacitinib over Otezla (apremilast) and placebo in treating adults with moderate to severe plaque psoriasis.
Bristol Myers Squibb today announced that the U.S. FDA has accepted the new drug application and the EMA has validated the marketing authorisation application for deucravacitinib for the treatment of adults with moderate to severe plaque psoriasis.
The FDA has assigned a Prescription Drug User Fee Act goal date of 10 September 2022.
These latest regulatory milestones are in addition to the NDA acceptance by Japan's Ministry of Health, Labour and Welfare for deucravacitinib for the treatment of adults with moderate to severe plaque psoriasis, pustular psoriasis and erythrodermic psoriasis.
