The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Novartis' 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).



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. Closely linked with psoriasis, PsA causes joint pain and stiffness, skin and nail psoriasis, swollen toes and fingers, persistent painful tendonitis and irreversible joint damage. Up to 40% of people can suffer from joint destruction and permanent physical deformity.

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.

Cosentyx is a human monoclonal antibody that selectively neutralizes IL-17A. IL-17A is found in high concentrations in skin affected by psoriasis and is a preferred target for investigational therapies. Research also shows that IL-17A plays an important role in driving the body's immune response in other inflammatory arthritic diseases, including psoriatic arthritis and ankylosing spondylitis.

Phase III development for psoriatic arthritis and ankylosing spondylitis is also underway; global regulatory applications for Cosentyx in these arthritic conditions are planned for 2015.

Psoriatic arthritis (PsA) is a debilitating, long-lasting inflammatory disease linked with significant disability, poor quality of life and reduced life expectancy. Between 0.3% and 1% of the general population may be affected by PsA and as many as one in four people with psoriasis may have undiagnosed PsA. PsA impacts over 3% of psoriasis patients in Japan.