2014 Issues   /   Pharmacy

FDA Approves Otezla for Active Psoriatic Arthritis

By U.S. Medicine

SUMMIT, NJ — Clinicians have a new tool in their arsenal to treat active psoriatic arthritis.

The Food and Drug Administration recently approved Otezla (apremilast) to treat adults with active psoriatic arthritis (PsA). The drug is marketed by Celgene Corporation, Summit, NJ.

Currently approved treatments for PsA — which usually occurs after patients are diagnosed with psoriasis and causes joint pain, stiffness and swelling — include corticosteroids, tumor necrosis factor (TNF) blockers, and an interleukin-12/interleukin-23 inhibitor.

“Relief of pain and inflammation and improving physical function are important treatment goals for patients with active psoriatic arthritis,” said Curtis Rosebraugh, MD, MPH., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research. “Otezla provides a new treatment option for patients suffering from this disease.”

Three clinical trials involving 1,439 patients with active PsA evaluated the safety and effectiveness of Otezla, an inhibitor of phosphodieasterase-4 (PDE-4). Study participants receiving Otezla showed improvement in signs and symptoms of PsA, including tender and swollen joints and physical function, compared to placebo.

The FDA recommends that patients treated with Otezla have their weight monitored regularly by a healthcare professional. In the case of unexplained or clinically significant weight loss, further evaluation should occur with the possibility of discontinuation of treatment. In addition, the agency noted that reports of depression increased compared to placebo in patients using the drug.

A pregnancy exposure registry assessing whether Otezla poses any risks to pregnant women or their unborn is a post-marketing requirement for approval. .

In clinical trials, the most common side effects observed were diarrhea, nausea and headache.

“Patients and physicians have expressed their desire for a safe and effective therapy for psoriatic arthritis that has the potential to simplify patient management. Celgene is excited to be expanding our transformational science into the therapeutic realm of Inflammation and Immunology, with a new approach for patients with psoriatic arthritis,” said Scott Smith, Global Head, Inflammation and Immunology, Celgene Corporation. “The FDA approval of Otezla is good news for patients and healthcare professionals who are looking for a different way to manage this disease.”


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