FDA approves Otezla for treatment of Plaque Psoriasis- Celgene

Celgene Corporation announced that the FDA has approved Otezla (apremilast), the Company's oral, selective inhibitor of phosphodiesterase 4 (PDE4), for the treatment of patients with moderate to severe Plaque Psoriasis for whom phototherapy or systemic therapy is appropriate. Otezla is the first and only PDE4 inhibitor approved for the treatment of Plaque Psoriasis.

Psoriasis, a chronic inflammatory disease of the skin resulting from an uncontrolled immune response, affects more than 125 million people worldwide. The approval of Otezla was based primarily on safety and efficacy results from two multi-center, randomized, double-blind, placebo-controlled studies - ESTEEM 1 and ESTEEM 2 - conducted in adult patients with moderate to severe Plaque Psoriasis.

Otezla was approved on March 21, 2014 by the FDA for the treatment of adults with active Psoriatic Arthritis.