Novartis announced that the US Food and Drug Administration (FDA) has approved a label update for Cosentyx (secukinumab), the first interleukin-17A (IL-17A) antagonist approved to treat moderate to severe plaque psoriasis.1
The updated label includes Cosentyx data in moderate to severe scalp psoriasis—one of the difficult-to-treat forms of the disease, which affects approximately half of all psoriasis patients.1-3 The label update is effective in the U.S. immediately, and is based on the proven efficacy and consistent safety profile of Cosentyx from a dedicated Phase III scalp psoriasis trial.6
The updated label for Cosentyx in scalp psoriasis addresses an important unmet need. Scalp psoriasis can be challenging to treat with topical agents or phototherapy due to the presence of hair and other factors.2 Approximately half of all 125 million patients with psoriasis may suffer from scalp psoriasis.2,4
“This is an important label update for Cosentyx, the first IL-17A inhibitor approved for moderate to severe plaque psoriasis. It confirms the additional value Cosentyx offers to patients who seek a treatment effective in various areas of the body,” said Eric Hughes, Global Development Unit head, immunology and dermatology. “We’re proud to expand treatment possibilities of Cosentyx for an even greater number of patients.”
Cosentyx is currently the only fully human IL-17A antagonist to demonstrate efficacy and safety in a dedicated Phase IIIb study of scalp psoriasis.6 The label update is based on 12-week primary endpoint results from the U.S. study of moderate to severe scalp psoriasis patients where Cosentyx (300 mg) demonstrated superior efficacy compared to placebo.1,6
Cosentyx, in a separate study, has demonstrated sustained long-term efficacy, as well as a safety profile consistent with that seen in pivotal trials.7 To date, more than 125,000 patients worldwide have been prescribed Cosentyx in the post-marketing setting across all indications since launch.8
1 Cosentyx [Prescribing Information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2018.
2 Crowley JJ. Nail, Scalp, and Palmoplantar Psoriasis. Biologic and Systemic Agents in Dermatology. 2018; 160-174.
3 National Psoriasis Foundation. Scalp Psoriasis. psoriasis.org. https://www.psoriasis.org/about-psoriasis/specific-locations/scalp. Accessed January 29, 2017.
4 Profile of Psoriasis. International Federation of Psoriasis Associations. https://www.worldpsoriasisday.com/web/page.aspx?refid=114. Published March 1, 2016. Accessed January 2, 2018.
5 European Medicines Agency. Cosentyx Summary of Product Characteristics. https://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003729/human_med_001832.jsp&mid=WC0b01ac058001d124. Updated July 17, 2017. Accessed January 2018.
6 Bagel J, Duffin KC, Moore A, et al. The effect of secukinumab on moderate-to-severe scalp psoriasis: Results of a 24-week, randomized, double-blind, placebo-controlled phase 3b study. J Am Acad Dermatol. 2017;77:667-674.
7 Bissonnette R, Luger T, Thaçi D, et al. Secukinumab demonstrates high sustained efficacy and a favorable safety profile through 5 years of treatment in moderate to severe psoriasis. EPoster presented at 26th EADV Congress; September 13-17, 2017, Geneva, Switzerland. Poster #P2223.
8 Data on File. Number of Patients Prescribed Cosentyx. Novartis Pharmaceuticals Corp; Nov. 2017.
Filed Under: Drug Discovery