On Oct. 31, 2023, Novartis announced that the US Food and Drug Administration (FDA) had approved Cosentyx (secukinumab) to treat moderate to severe hidradenitis suppurativa (HS) 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 HS.

HS 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 HS 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 HS.

The FDA approval was based on analyses from the largest Phase III program in HS 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.¹ Cosentyx for HS 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.

In both the SUNSHINE and SUNRISE studies, which evaluated Cosentyx across 16-week (vs placebo) and 52-week treatment periods, the onset of action of Cosentyx occurred as early as Week 2. Efficacy progressively increased to Week 16 and was observed up to Week 52.

The safety profile of Cosentyx observed in these HS trials was consistent with its known safety profile observed in the plaque psoriasis trials, affirming the differentiated safety profile of Cosentyx