Novartis AG (ADR) (NVS)’s Cosentyx Gets Clearance In Europe
Novartis AG (ADR) (NYSE:NVS)’s Cosentyx™ gets the European Commission approval to be the first-line treatment of moderate-to-severe plaque psoriasis in adults requiring systemic therapy. Cosentyx™ has already been approved in Australia and Japan for the treatment of this condition and the U.S. FDA decision is expected in early 2015. The drug is also approved in Japan for the treatment of active psoriatic arthritis.
The Dermatologic and Ophthalmic Drugs Advisory Committee to the U.S. FDA has already has already passed a unanimous recommendation of approval in October 2014 for use of Cosentyx™ in moderate-to-severe plaque psoriasis.
David Epstein, Division Head at Novartis AG (ADR) (NYSE:NVS), said that EC approval is groundbreaking news and would help many psoriasis patients to achieve clear skin. Epstein also pointed at significant unmet need for patients living with psoriasis citing nearly half of them are not satisfied with current therapies. Cosentyx as a systemic therapy would offer a better chance of getting clear or almost clear skin.
Cosentyx is the only interleukin-17A inhibitor to be approved in Europe, providing a new first-line biologic treatment option for patients living with psoriasis. Currently available biologic treatments including Stelara and anti-TNFs (anti-tumor necrosis factor) therapies are recommended for psoriasis as second-line systemic therapy in Europe.
The European approval follows the promising results of the Phase IIIB CLEAR study that demonstrated Cosentyx to be superior to Stelara in clearing skin of patients with moderate-to-severe plaque psoriasis. Cosentyx also demonstrated better efficacy than Enbrel in clearing skin in the FIXTURE study. The drug also demonstrated favorable overall safety profile in the Phase III studies, with minimal differences observed between Enbrel and Stelara in head-to-head comparison.
Data from Novartis AG (ADR) (NYSE:NVS)’s Cosentyx related clinical program also showed a positive correlation between achieving clear to almost clear skin and health-related quality of life in patients living with psoriasis.
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