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# Novartis Gains Expanded Label for Cosentyx
- URL: https://www.fdaweb.com/novartis-gains-expanded-label-for-cosentyx/
- Published: 2018-02-08T12:00:00.000Z
- Updated: 2026-09-14T23:21:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140718

FDA has approved a Novartis supplemental BLA for Cosentyx (secukinumab) to update its label to include moderate-to-severe scalp psoriasis. Expanded approval was based on data from a Phase 3 trial in scalp psoriasis patients where Cosentyx demonstrated superior efficacy compared to placebo, the company says. The human interleukin-17A inhibitor was originally approved in 2015 for treating adults with moderate-to-severe plaque psoriasis.  
  
Secukinumab is an antibody that binds to a protein (interleukin-17A) which has a role in inflammation. “By binding to IL-17A, secukinumab prevents it from binding to its receptor, and inhibits its ability to trigger the inflammatory response that plays a role in the development of plaque psoriasis,” an FDA [news release](http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm430969.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery) says. Cosentyx is injected under the skin and is intended for patients who are candidates for systemic therapy, phototherapy (ultraviolet light treatment) or a combination of both.  
  
Cosentyx was approved with a Medication Guide to inform patients they may have a greater risk of getting an infection. “Caution should be exercised when considering the use of Cosentyx in patients with a chronic infection or history of recurrent infection, and in patients with active Crohn’s Disease,” the agency says.