Novartis Gets First Regulatory OK for Secukinumab
Novartis reports that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Cosentyx (secukinumab), an interleukin-17A (IL-17A) inhibitor for treating psoriasis vulgaris and psoriatic arthritis (PsA) in adults, marking the first regulatory approval of the drug. The drug is indicated to treat who are not adequately responding to systemic therapies (except for biologics).
Cosentyx received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommending it as a first-line treatment of moderate-to-severe psoriasis patients in Europe in November 2014. The US Food and Drug Administration (FDA) approval in the same indication is anticipated in early 2015 following the recommendation for approval in October 2014 from the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee.
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, according to information from Novartis.
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.
Source: Novartis