Novartis' Cosentyx Approved In Japan For Both Psoriasis And Psoriatic Arthritis

(RTTNews) - Novartis (NVS) said Friday that the Japanese Ministry of Health, Labour and Welfare or MHLW approved Cosentyx (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 (except for biologics).

The company noted that the approval marks the first country approval for Cosentyx in the world and makes it the first interleukin-17A or IL-17A inhibitor to receive regulatory approval in either of these indications in Japan.

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 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 or AEs between Cosentyx treatment arms (300 mg and 150 mg).

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.

Psoriatic arthritis is a debilitating, long-lasting inflammatory disease linked with significant disability, poor quality of life and reduced life expectancy.

The company said that the US Food and Drug Administration 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.