Celgene Corp. (CELG) said Friday that the U.S. Food and Drug Administration has approved OTEZLA, the company's oral, selective inhibitor of phosphodiesterase 4, for the treatment of adult patients with active psoriatic arthritis.
A chronic disorder, psoriatic arthritis is characterized by pain, stiffness, swelling and tenderness of the joints, inflammation of specific ligaments and tendons, and a decrease in physical functioning.
OTEZLA is the only FDA-approved oral treatment for psoriatic arthritis.
The approval was based on safety and efficacy results from three multi-center, randomized, double-blind, placebo-controlled trials - PALACE 1, 2 and 3 - conducted in adult patients with active psoriatic arthritis who were inadequately controlled by disease-modifying anti-rheumatic drugs and/or biologics. More than 75% of patients were previously treated with DMARDs only and 22% of patients were previously treated with biologics.
OTEZLA is expected to be available in the U.S. in March.
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