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FDA approves Celgene's apremilast

March 22, 2014 12:54 AM UTC

FDA approved an NDA for Otezla apremilast from Celgene Corp. (NASDAQ:CELG) to treat adults with active psoriatic arthritis. The company plans to launch the oral phosphodiesterase-4 (PDE-4) inhibitor this month with a wholesale acquisition cost (WAC) of $22,500 for a typical course of therapy. Otezla is still under FDA review to treat moderate to severe psoriasis, with a Sept. 23 PDUFA date. In January, Celgene disclosed that it submitted an MAA to EMA for Otezla to treat moderate to severe psoriasis and psoriatic arthritis. ...