FDA approves Otezla for treatment of plaque psoriasis

Celgene Corporation announced that the U.S. Food and Drug Administration has approved Otezla for the treatment of patients with moderate to severe plaque psoriasis.

Perspective from Mark G. Lebwohl, MD

Otezla (apremilast) is the only selective inhibitor of phosphodiesterase 4 (PDE4) inhibitor approved for the treatment of plaque psoriasis, according to a company press release.

The approval of apremilast comes after two multicenter, randomized, double-blind, placebo-controlled studies, ESTEEM 1 and ESTEEM 2, conducted in adult patients with moderate to severe plaque psoriasis. During the studies, patients experienced clinically meaningful PASI score improvements at week 16.

Apremilast was approved by the FDA on March 21 for the treatment of adults with active psoriatic arthritis.

The drug is available in the U.S. and is dispensed through a comprehensive network of specialty pharmacies, according to the release.

For more information about apremilast distribution and the exclusive treatment support services, including reimbursement assistance and 24/7 nurse support, doctors and patients can contact Otezla SupportPlus at 1-844-4OTEZLA (1-844-468-3952) or visit www.otezla.com for more information.

Perspective

Mark G. Lebwohl, MD

Apremilast is the first oral drug approved for psoriasis in decades. Several injectable drugs have been introduced for psoriasis in recent years. This adds a safe, useful therapeutic option for patients with this debilitating condition. The approval of this drug will offer the millions of Americans affected by psoriasis, and their doctors, an oral treatment option that works differently from other psoriasis medications. If approved, it will be the first and only inhibitor of phosphodiesterase 4 (PDE4) approved for this indication. As an oral medication, apremilast offers patients a way to treat their illness with minimal disruption in their day-to-day lives.

Mark G. Lebwohl, MD

Sol and Clara Kest Professor of Dermatology and Chair of the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai and president-elect of the American Academy of Dermatology

Disclosures: Lebwohl consults for: Actelion Pharmaceuticals Ltd.; Applied Biology, Inc.; Celsus Therapeutics Plc; Columbia Laboratories, Inc.; Coronado Biosciences; Covagen AG; Dermira; Forward Pharma; Genentech, Inc.; Meda Pharmaceuticals; Merck & Co., Inc.; Onset Dermatologics LLC; Pfizer Inc.; PharmAthene, Inc.; Sandoz (Hexal AG); Taro Pharmaceuticals U.S.A., Inc.; Thesan Pharmaceuticals; UCB S.A.; Valeant Pharmaceuticals International, Inc.; Xoma (US) LLC.