Advisors to the US Food and Drug Administration have voted unanimously to support approval of Novartis’ secukinumab for moderate-to-severe plaque psoriasis.
The agency’s Dermatologic and Ophthalmic Drugs Advisory Committee voted 7-0 in favour of secukinumab, a selective interleukin-17A inhibitor, based on 10 Phase II/III clinical studies which included nearly 4,000 patients. Treatment with the drug has resulted in high rates of clear to almost clear skin at week 12 and it has shown superiority to Amgen’s Enbrel (etanercept), an anti-TNF standard of care.
If approved, and a final decision is expected by early 2015, secukinumab will be the first IL-17A inhibitor on the market, while a number of others are coming up on the rails in that class, notably Amgen and AstraZeneca’s brodalumab and Eli Lilly’s ixekizumab.
Secukinumab will be competing with the biologics but Novartis is confident there is a sizeable market for its treatment. The Swiss major cited an analysis of surveys conducted of 5,600 patients by the National Psoriasis Foundation between 2003 and 2011 showing that 52% were dissatisfied with their disease management.
