Novartis announces FDA Advisory Committee unanimously recommends approval of AIN457 (secukinumab) for patients with moderate-to-severe plaque psoriasis

Novartis International AG / Novartis announces FDA Advisory Committee unanimously recommends approval of AIN457 (secukinumab) for patients with moderate-to-severe plaque psoriasis . Processed and transmitted by NASDAQ OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement.

• Biologics License Application (BLA) for secukinumab, a "first-in-class" IL-17A inhibitor, is currently under FDA review with an anticipated action date in early 2015
   

FDA Advisory Committee recommendation based on efficacy and safety outcomes of 10 Phase II/III clinical studies of secukinumab in moderate-to-severe plaque psoriasis
 

Affecting 7.5 million Americans, psoriasis may negatively impact daily life and is associated with increased risk for other chronic illnesses[1]-[3]
 

National Psoriasis Foundation survey of 5,600 patients found 52% were dissatisfied with their disease management[4]

Basel, 20 October, 2014 - Novartis announced the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) to the US Food and Drug Administration (FDA) today voted unanimously 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). The DODAC based its recommendation on the safety and efficacy outcomes from 10 psoriasis Phase II/III clinical studies which included nearly 4,000 patients with moderate-to-severe plaque psoriasis.

"Moderate-to-severe psoriasis is a serious condition where patients suffer from skin lesions that cause itching, pain and scaling. There is a need for novel therapies as not all treatments are appropriate or effective in every patient," said Vas Narasimhan, Global Head Development, Novartis Pharmaceuticals. "Today's recommendation is based on the efficacy and safety data put forth in our robust clinical trial program and brings us one step closer to delivering an innovative, new treatment option for people suffering from moderate-to-severe psoriasis. We look forward to working with the FDA as it finalizes its review."