FDA Approves Novartis' Cosentyx To Treat Moderate To Severe Hidradenitis Suppurativa In Adults

(RTTNews) - Novartis (NVS) said that the US Food and Drug Administration has approved Cosentyx (secukinumab) to treat moderate to severe hidradenitis suppurativa in adults.

Cosentyx is the only FDA-approved fully human biologic that directly inhibits interleukin-17A (IL-17A), a cytokine believed to be involved in the inflammation of hidradenitis suppurativa.

The FDA approval was based on analyses from the largest Phase III program in hidradenitis suppurativa to date, SUNSHINE and SUNRISE, in which a higher proportion of patients given Cosentyx 300 mg either every two weeks or every four weeks achieved a Hidradenitis Suppurativa Clinical Response (HiSCR50) compared to placebo.

Cosentyx for hidradenitis suppurativa is approved as a 300 mg dose, administered every four weeks, with the option to increase to every two weeks if the patient has an inadequate response.

Hidradenitis suppurativa is a chronic, systemic and often painful skin disease that causes recurring boil-like lumps that may burst into open wounds and cause irreversible scarring, often in the most intimate parts of the body. It may take people living with hidradenitis suppurativa an average of up to 10 years to get a correct diagnosis, which can result in disease progression and significantly impact their quality of life. Until now, there has been only one biologic approved to treat hidradenitis suppurativa.

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