New Biologic Treatment for Hidradenitis Suppurativa Receives FDA Approval

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This is the second biologic approved to treat HS, a painful and reoccurring skin disease.

On Oct 31, 2023, Novartis announced FDA’s approval of Cosentyx (secukinumab) as a treatment for adults with moderate to severe hidradenitis suppurativa (HS). As reported by Novartis, Cosentyx is the only FDA-approved fully human biologic that directly inhibits interleukin-17A (IL17A), a cytokine (a small signaling protein) believed to be connected to the inflammation of HS. Secukinumab is the second biologic approved to treat HS.

HS is a chronic, systemic, and painful skin disease whose symptoms include recurring boil-like lumps which can burst into open wounds, often in sensitive areas, causing irreversible damage. Many patients seeking treatment have a more developed form of HS, as it can take them up to 10 years to get a correct diagnosis. For those individuals, HS can significantly impact their quality of life.

The FDA approval was based on evidence from, as reported by Novartis, the largest Phase II program in HS as of the publication of this article. Cosentyx has been studied clinically for more than 14 years and has treated more than 1 million patients worldwide since 2015.


“Cosentyx can offer effective, lasting relief from HS symptoms so that people with HS have a chance to live every day with confidence,” said Victor Bultó, president, Novartis US, in a Novartis press release. “With this sixth indication approval for Cosentyx—along with ongoing studies in numerous other conditions—we are reaffirming our commitment to reimagine medicine for those living with immunological diseases.”

Source: Novartis