06 February 2015 | News | By BioSpectrum Bureau
Novartis' Cosentyx receives Japanese nod
Japan is the first country to approve Cosentyx
Singapore: The Japanese Ministry for Health and Welfare has recently given its nod for Novatris' Cosentyx, that treats psoriasis and vulgaris in adults.
This approval marks the first country approval for Cosentyx in the world and makes it the first interleukin-17A (IL-17A) inhibitor to receive regulatory approval in either of these indications in Japan.
The drug works by inhibiting the action of IL-17A, a protein, found in high concentrations in skin affected by psoriasis and central to the development of inflammatory diseases, including psoriasis. With this approval, the Japanese can have access to a new treatment option that treats both the diseases.
Psoriasis is a chronic immune-mediated disease characterized by thick and extensive skin lesions, called plaques, known to cause itching, scaling and pain; it is associated with significant impairment of physical and psychological quality of life.
The 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.