WASHINGTON — The U.S. Food and Drug Administration (FDA) has granted approval to Novartis for their drug Cosentyx as a treatment for adults suffering from moderate to severe hidradenitis suppurativa, a chronic inflammatory skin condition, the company revealed on Tuesday.
Cosentyx marks a significant milestone as the first new biologic treatment option to receive FDA approval for hidradenitis suppurativa in almost a decade. This autoimmune disorder results in painful, boil-like lumps developing beneath the skin, which can rupture and cause scarring.
The decision to clear Cosentyx for this application is grounded in the positive outcomes of Novartis' Phase 3 Sunshine and Sunrise clinical trials, which demonstrated the drug's efficacy in managing the condition. The trials indicated that a notably higher percentage of patients receiving Cosentyx observed the resolution of their hidradenitis suppurativa symptoms in comparison to those who received a placebo.
Before this approval, only one other FDA-approved biologic treatment existed for hidradenitis suppurativa. This new development provides a fresh therapeutic option for patients grappling with the challenges of this debilitating skin ailment.
Cosentyx, a fully human monoclonal antibody that targets interleukin-17A, a protein involved in inflammatory conditions, initially obtained FDA approval in 2015 for the treatment of psoriasis and other inflammatory diseases.
The most recent FDA clearance broadens the application of Cosentyx to include hidradenitis suppurativa, addressing an unmet need for more effective treatments. Novartis has plans to make the drug available in the coming weeks.
Facts Bulletins - Source
Comments
Post a Comment