NAPSR News: FDA Approves Celgene’s OTEZLA® to Treat Plaque Psoriasis

WASHINGTON - Sept. 24, 2014 - PRLog -- The U.S. Food and Drug Administration (FDA) has approved OTEZLA® (apremilast) administered as a oral, selective inhibitor of phosphodiesterase 4 (PDE40 to treat  patients with with moderate to severe plaque psoriasis for whom phototherapy or systemic therapy is appropriate. The approval of OTEZLA represents the first and only PDE4 inhibitor to treat plaque psoriasis. Psoriasis is a chronic inflammatory disease of the skin and currently affects more than 125 million worldwide.

"OTEZLA offers an important new treatment option for patients whose symptoms are not adequately improving with their current treatments. In clinical trials, OTEZLA reduced redness, thickness, and scaliness of plaques in patients with moderate or severe plaque psoriasis," said Dr. M. Shane Chapman, Section Chief of Dermatology at Dartmouth-Hitchcock Medical Center. "Because the product labeling does not require routine laboratory monitoring, oral OTEZLA may be a welcome new option for patients and physicians looking for a different treatment experience."

OTEZLA’s approval was based on safety and efficacy results from two multi-center, randomized, double-blind, placebo-controlled studies - ESTEEM 1 and ESTEEM  2 assessed in 1,426 adult patients with moderate to severe plaque psoriasis.

Otezla is already available in the USA gaining FDA approval in March to treat adults with active psoriatic arthritis and with the new approved indication sales are expected to increase. According to Bloomberg analysts the drug is expected to generate $1.03 billion in sales in 2017.

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