FDA Approves First IL-17A antagonist Cosentyx (secukinumab) from Novartis for Moderate to Severe Plaque Psoriasis

The FDA approved Cosentyx™ (secukinumab) from Novartis for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. Cosentyx is the first approved psoriasis medication to selectively bind to IL-17A and inhibit its interaction with the IL-17 receptor. The approval is based on the efficacy and safety outcomes from 10 Phase II and III studies, including over 3,990 patients with moderate-to-severe plaque psoriasis, which demonstrated that Cosentyx resulted in clear or almost clear skin in the majority of patients and had an acceptable safety profile.

"We have heard first-hand from patients and doctors about the negative impact of psoriasis and the need for innovative therapies. With the FDA approval of Cosentyx, a majority of people living with moderate-to-severe plaque psoriasis in the US now have available a new medication that can help them achieve clear or almost clear skin," said Christi Shaw, US Country Head, President of Novartis Corporation and Novartis Pharmaceuticals Corporation. "As the first approved treatment targeting the IL-17A pathway, which is believed to play a key role in the development of psoriasis, we are confident this novel treatment will make a difference for the psoriasis community."

"I have treated many patients with moderate-to-severe plaque psoriasis and have seen the significant physical impact the disease can have. Psoriasis plaques are scaly, itchy and painful all of which can have a significant impact on many aspects of a patient's life," said Andrew Blauvelt, MD, MBA, President of the Oregon Medical Research Center. "I'm excited to be able to offer my patients a new treatment option with Cosentyx, which showed significant skin clearance in large scale clinical trials."

The Phase III clinical program included four placebo-controlled studies, which examined Cosentyx 300 mg and 150 mg in patients with moderate-to-severe plaque psoriasis. In these studies, Cosentyx 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) 0/1 responses, showing significant skin clearance at Week 12.

"Psoriasis has a profound emotional, social and psychological impact on many people," said Randy Beranek, president and CEO of the National Psoriasis Foundation. "The approval of Cosentyx for the physical signs and symptoms of the disease is significant for patients and their health care providers as it offers another treatment option for moderate-to-severe plaque psoriasis. What works to treat one person's psoriasis may not work for another, so we're excited that there is a new option on the market.