Celgene: FDA Okays Oral Otezla To Treat Patients With Plaque Psoriasis

(RTTNews) - Celgene Corp (CELG) said Tuesday the U.S. Food and Drug Administration 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 positive results from randomized, double-blind, placebo-controlled studies that studies 1,426 patients.

Side effects of Otezla were diarrhea, nausea, upper respiratory tract infection, tension headache, and headache.

Otezla is available in the U.S. and is dispensed through a comprehensive network of specialty pharmacies.

Otezla was approved on March 21, 2014 by the FDA for the treatment of adults with active psoriatic arthritis. A New Drug Submission for psoriatic arthritis was submitted to health authorities in Canada in the second quarter of 2013.

Celgene stock is trading at $93.46, up $1.27 or 1.38%, on a volume of 2.9 million shares on the Nasdaq.