Published 25 November 2014

Celgene International Srl, a wholly-owned subsidiary of Celgene Corporation, announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for OTEZLA (apremilast), the Company's oral selective inhibitor of phosphodiesterase 4 (PDE4), in two therapeutic indications:

Psoriasis is an immune mediated skin condition characterised by raised scaly lesions on the skin. It affects approximately 14 million people across Europe and about 125 million people worldwide.

Plaque psoriasis, also called psoriasis vulgaris, is the most common form of the disease, representing about 80 percent of cases. Up to 30 percent of people with psoriasis may develop psoriatic arthritis, which involves pain and swelling in jointsand other manifestations and may lead to significant disability.

"This CHMP positive opinion is an important step forward for people with psoriasis and psoriatic arthritis in Europe. These immune mediated diseases are frequently debilitating and cause severe physical and emotional pain to the individual," stated Tuomo Ptsi, President, Celgene Europe, the Middle East and Africa (EMEA).

"We are proud to have moved one step closer to offering patients OTEZLA, a new, oral treatment approach that could significantly help control their symptoms and make a considerable difference to their quality of life."

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 (a 75 percent improvement in the Psoriasis Area Severity Index) 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.

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.

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Celgene gets positive CHMP opinion for OTEZLA to treat psoriasis and psoriatic arthritis