First in the World Regulatory Approval of Novartis' Cosentyx in Japan for Both Psoriasis and Psoriatic Arthritis?

Novartis has announced 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 who are not adequately responding to systemic* therapies (except for biologics). 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.

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. As approximately 30% of psoriasis patients are also affected by PsA globally, this approval means that these patients in Japan now have a new treatment option that effectively treats both diseases.

"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."

In psoriasis clinical trials, 70% of patients achieved clear or almost clear skin within the first 16 weeks of treatment with Cosentyx 300 mg (p<0.0001), which was maintained in the majority of patients up to Week 52 (with continued treatment). In the PsA trials, Cosentyx demonstrated significant and sustained efficacy versus placebo in improving signs and symptoms of PsA, as measured by a 20% reduction in the American College of Rheumatology response criteria (ACR 20), which is a standard criteria to assess the effectiveness of arthritis treatments. Between 50% to 54% of Cosentyx patients achieved at least ACR 20 in two pivotal studies, FUTURE 1 (150 mg; p<0.0001) and FUTURE 2 (150 and 300 mg; p<0.0001).

This approval was based on the safety and efficacy results from more than 10 Phase II and Phase III studies which included nearly 4000 patients with moderate-to-severe plaque psoriasis and supported by two pivotal Phase III studies, FUTURE 1 and FUTURE 2, involving more than 1000 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 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.