Novartis Psoriasis Drug Approved In Japan

Swiss pharmaceutical giant Novartis AG (NVS: Quote) said Friday that Cosentyx has been approved in Japan for both psoriasis vulgaris and psoriatic arthritis, marking the first country approval for Cosentyx in the world. The approval also makes Cosentyx the first interleukin-17A or IL-17A inhibitor to receive regulatory approval in either of these indications in Japan.

Novartis said that the Japanese Ministry of Health, Labour and Welfare approved Cosentyx or secukinumab, formerly known as AIN457, for the treatment of both psoriasis vulgaris and psoriatic arthritis or PsA in adults who are not adequately responding to systemic therapies.

David Epstein, Division Head, Novartis Pharmaceuticals said, "We are pleased that Japan is the first country to approve Cosentyx for both psoriasis and psoriatic arthritis, providing an alternative treatment option for more than 400,000 Japanese citizens who are living with psoriasis, and those also living with psoriatic arthritis."

Psoriasis is a chronic immune-mediated disease characterized by thick and extensive skin lesions, called plaques. The plaques are known to cause itching, scaling and pain, and is associated with significant impairment of physical and psychological quality of life.

Closely linked with psoriasis, PsA causes joint pain and stiffness, skin and nail psoriasis, swollen toes and fingers, persistent painful tendonitis and irreversible joint damage. Psoriatic arthritis affects 30 percent of psoriasis patients globally and can cause irreversible joint damage.

Cosentyx works by inhibiting the action of IL-17A, a protein that is found in high concentrations in skin affected by psoriasis and central to the development of inflammatory diseases, including psoriasis and PsA.

Novartis noted that many patients do not respond to or tolerate current psoriasis or psoriatic arthritis treatments, indicating an unmet need for new therapies for these diseases. The company noted that with today's approval, these patients now have a new treatment option that effectively treats both diseases.

The Japanese approval was based on the safety and efficacy results from more than 10 Phase II and Phase III studies, which included nearly 4,000 patients with moderate-to-severe plaque psoriasis.

It was also supported by two pivotal Phase III studies, FUTURE 1 and FUTURE 2, involving more than 1,000 patients with PsA. In all studies, Cosentyx demonstrated a favorable safety profile, with similar incidence and severity of adverse events between Cosentyx treatment arms of 300 mg and 150 mg.

Novartis obtained a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use or CHMP in November 2014, recommending Cosentyx as a first-line treatment of moderate-to-severe psoriasis patients in Europe.

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Novartis Psoriasis Drug Approved In Japan