CHMP recommends approval of Otezla for Psoriatic Arthritis-Celgene

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Otezla (apremilast), from Celgene, alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs), for the treatment of active Psoriatic Arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy.

In the PALACE program, which forms the basis for CHMP’s positive opinion for apremilast in psoriatic arthritis, treatment resulted in significant and clinically meaningful improvements in the signs and symptoms of psoriatic arthritis, as measured by the modified ACR-20 (a 20 percent improvement in the American College of Rheumatology disease activity criteria) response at 16 weeks, the primary endpoint. Patients on apremilast showed improvement across multiple disease manifestations specific to psoriatic arthritis, such as swollen and tender joints, as well as dactylitis, enthesitis and overall physical function.