FDA
21st October 2014

FDA Panel Unanimously Recommends Approval of AIN457 (secukinumab)

Yesterday, the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) voted unanimously in favor of approving Novartis’ AIN457 (secukinumab) for moderate-to-severe plaque psoriasis.

FDA Panel Unanimously Recommends Approval of AIN457 (secukinumab)

Yesterday, the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) voted unanimously in favor of approving Novartis’ AIN457 (secukinumab) for moderate-to-severe plaque psoriasis. The materials for this meeting can be found HERE.

DODAC voted 7-0  in favor of secukinumab, a selective interleukin-17A inhibitor, based on 10 Phase II/III clinical studies which included nearly 4,000 patients. The studies showed that treatment with secukinumab 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.

Currently, the most common treatment option for individuals suffering from psoriasis are injectable therapies that inhibit tumor necrosis factor (TNF); however, Novartis emphasized a survey by the National Psoriasis Foundation in which over half of patients with psoriasis are still dissatisfied with their disease management. 

Vas Narasimhan, Novartis Global Head of Development, stated that “there is a need for novel therapies, as not all treatments are appropriate or effective in every patient.” He added, “..the advisory committee decision brings us one step closer to delivering an innovative, new treatment option for people suffering from moderate-to-severe psoriasis.” 

The FDA is not bound by its panel’s recommendations; however, they normally take them into consideration. If approved, secukinumab will be the first IL-17A inhibitor on the market. A final decision is expected by early 2015.

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComs per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net.

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