FDA Panel Unanimously Backs Secukinumab for the Treatment of Psoriasis

FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee voted 7-0 to recommend approval of Novartis’ AIN457 (secukinumab) for the treatment of plaque psoriasis for patients who are candidates for systemic therapy or phototherapy. The panel determined the drug was highly efficacious and the 300 mg dose was determined to provide the greatest benefit to patients. When compared with Enbrel (etanercept) in a head-to-head trial last year, secukinumab demonstrated significantly superior efficacy over Enbrel in patients with moderate-to-severe plaque psoriasis.

Unlike many of the tumor necrosis factor (TNF) inhibitors used to treat psoriasis, secukinumab employs a unique first-in-class mechanism of action. The drug, a human IgG1 mAb, targets the function of proinflammatory cytokine IL-17A, a messenger protein typically found in high concentrations in psoriasis skin plaques. IL-17A recruits monocytes and neutrophils to the site of inflammation, and psoriasis patients’ skin is in a constant state of inflammation as a result of this IL-17A activity. Secukinumab works by neutralizing the function of this interleukin.

Assuming secukinumab goes on to win FDA approval, it may have a significant impact on clinical decisions and payer policies, as Enbrel is currently considered the standard of care to treat psoriasis and is the most commonly used drug among TNF inhibitors, according to a study by the Journal of Managed Care Pharmacy.

Novartis filed a biologics license application for secukinumab in October 2013, and the anticipated action date for the drug is in early 2015. Although FDA is not obligated to approve the drug based on the panel’s recommendations, the agency typically approves medications based on panel sanctions.

Sources:
Novartis
http://www.novartis.com/newsroom/media-releases/en/2014/1864296.shtml

http://www.novartis.com/newsroom/media-releases/en/2013/1733280.shtml