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news.The US Food and Drug Administration's (FDA) Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) has approved Novartis' AIN457 (secukinumab), a selective interleukin-17A (IL-17A) inhibitor, to treat moderate-to-severe plaque psoriasis in adult patients.
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The DODAC recommendation is based on the safety and efficacy outcomes from ten psoriasis Phase II/III clinical trials which included nearly 4,000 patients with moderate-to-severe plaque psoriasis.
Novartis Pharmaceuticals global head development Vas Narasimhan said 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," Narasimhan said.
"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."
The Phase III clinical program for secukinumab included four placebo-controlled pivotal trials which examined secukinumab 300mg and 150mg in patients with moderate-to-severe plaque psoriasis.
In these studies, secukinumab met all primary and key secondary endpoints, including Psoriasis Area and Severity Index (PASI) 75 and 90 and Investigator’s Global Assessment modified 2011 (IGA mod 2011) 0/1 responses, showing significant skin clearance at Week 12.
The company submitted a Biologics License Application (BLA) for secukinumab to the FDA in October 2013 and the FDA action date is expected in early 2015.