FDA clears apremilast for psoriatic arthritis

By Reuters Staff

(Reuters) - U.S. health regulators on Friday approved a Celgene Corp drug to treat psoriatic arthritis, a type of arthritis associated with psoriasis that causes joint pain, stiffness and swelling.

The drug, known chemically as apremilast, will be sold under the brand name Otezla. It is also being studied by the U.S. biotechnology company as a treatment for psoriasis and ankylosing spondylitis.

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"Relief of pain and inflammation and improving physical function are important treatment goals for patients with active psoriatic arthritis," Curtis Rosebraugh, director of the FDA Office of Drug Evaluation II, said in a statement.

"Otezla provides a new treatment option for patients suffering from this disease," he added.

As a condition of approval, the FDA is requiring a registry of pregnant women who use the drug to assess the risks to pregnant women related to Otezla exposure, the agency said.

It also said patients taking Otezla should be monitored for potentially significant weight loss. If unexplained or clinically significant weight loss occurs, the weight loss should be evaluated and discontinuation of treatment should be considered, the FDA said.

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