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U.S. FDA approves Otezla to treat psoriatic arthritis

English.news.cn   2014-03-22 06:32:47

WASHINGTON, March 21 (Xinhua) -- The U.S. Food and Drug Administration (FDA) on Friday approved Otezla, chemically known as apremilast, to treat adults with active psoriatic arthritis, a form of arthritis that causes joint pain, stiffness and swelling.

The FDA said in a statement that most people develop psoriasis first and are later diagnosed with psoriatic arthritis. Currently approved treatments include corticosteroids, tumor necrosis factor 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, 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."

The safety and effectiveness of Otezla, manufactured by U.S.- based Celgene Corp., were evaluated in three clinical trials involving 1,493 patients with active psoriatic arthritis. Patients treated with Otezla showed improvement in signs and symptoms, including tender and swollen joints and physical function, compared to placebo, the FDA said. The most common side effects observed were diarrhea, nausea, and headache.

The agency said patients treated with Otezla should have their weight monitored regularly by a healthcare professional.

If unexplained or clinically significant weight loss occurs, the loss should be evaluated and discontinuation of treatment should be considered, it said.

Treatment with Otezla was also associated with an increase in reports of depression compared to placebo.

As a post-marketing requirement, the FDA said it required a pregnancy exposure registry to assess the risks to pregnant women related to Otezla exposure.

Editor: yan
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