SUMMIT (dpa-AFX) - Celgene International Sàrl, a wholly owned subsidiary of Celgene Corporation (CELG) announced that the European Medicines Agency's or EMA Committee for Medicinal Products for Human Use or CHMP has adopted a positive opinion for OTEZLA, (apremilast), the company's oral selective inhibitor of phosphodiesterase 4.
In the ESTEEM studies, which form the basis of CHMP's positive opinion for apremilast in psoriasis, treatment resulted in significant and clinically meaningful improvements in plaque psoriasis as measured by PASI-75 scores at week 16, the primary endpoint. Patients on apremilast also benefited from significant improvements in difficult to treat areas, such as nail and scalp, and itch, known to have a marked impact on patients' quality of life and perception of disease severity, according to the company.
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 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.
Across these phase III clinical studies, the most commonly reported adverse reactions were consistently diarrhoea, nausea, upper respiratory tract infection, tension headache and headache.
Celgene said OTEZLA was approved on March 21, 2014 by the U.S. Food and Drug Administration or FDA for the treatment of adults with active psoriatic arthritis and on September 23, 2014 for the treatment of patients with moderate to severe plaque psoriasis. In Canada, OTEZLA was approved for the treatment of moderate-to-severe plaque psoriasis in November 2014.
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