SILVER SPRING, Md. -- The oral phosphodiesterase-4 inhibitor apremilast can be marketed as a treatment for psoriatic arthritis in adults, the FDA said Friday.
It will be sold by Celgene with the brand name Otezla.
In announcing the approval, the FDA . Those receiving the drug "showed improvement in signs and symptoms of psoriatic arthritis, including tender and swollen joints and physical function, compared to placebo," the agency said.
Because the drug may pose risks during pregnancy, Celgene will be required to establish a pregnancy exposure registry for patients treated with apremilast.
Another potential adverse effect cited by the agency is weight loss -- the drug's label will include a recommendation to monitor patients' weight and consider discontinuing the drug if weight loss becomes a clinical concern.
Common side effects seen in the clinical trials included diarrhea, nausea, and headache.
Apremilast has also been studied as a treatment for psoriasis, ankylosing spondylitis, and atopic dermatitis. The psoriatic arthritis approval is the drug's first.