FDA Advisory Committee Recommends Novartis Biologic for Approval

Novartis reports that the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) to the US Food and Drug Administration (FDA) has unanimously voted to support the approval of AIN457 (secukinumab), a selective interleukin-17A (IL-17A) inhibitor, for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy (a drug that is absorbed into the bloodstream and distributed to all parts of the body) or phototherapy (light therapy).

Novartis submitted a biologics license application (BLA) for secukinumab to the FDA in October 2013, and the FDA action date is expected in early 2015. Additionally, submissions have been made with regulatory authorities in the European Union with an expected decision anticipated in late 2014 or early 2015.

Source: Novartis

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