Health Boards
More good news today for Cosentyx (secukinumab) as they today announce receiving full approval for it's use in Japan for treating psoriasis.
Source: NO LINKS ALLOWED
Quote:
Novartis announced today that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved Cosentyx™ (secukinumab, formerly known as AIN457), for the treatment of both psoriasis vulgaris and psoriatic arthritis (PsA) in adults.
"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," said David Epstein, Division Head, Novartis Pharmaceuticals. "Nearly half of patients with psoriasis and PsA are unhappy with their current therapies. With this approval, we are able to address this critical unmet need and aim to make a real difference in the quality of life of these patients."
This 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 and 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 (AEs) between Cosentyx treatment arms (300 mg and 150 mg).
The positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommending Cosentyx as a first-line treatment of moderate-to-severe psoriasis patients in Europe was obtained in November 2014. US Food and Drug Administration (FDA) approval in the same indication is anticipated in early 2015 following the unanimous recommendation of approval in October 2014 from the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) to the US FDA.
Source: NO LINKS ALLOWED