FDA approves Novartis Cosentyx as the first new biologic treatment option for hidradenitis suppurativa patients in nearly a decade

Novartis, a global leader in immuno-dermatology and rheumatology, announced that the US Food and Drug Administration (FDA) has 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.

“For many patients, the daily impact of HS and the search for symptom relief can last years – which can come with painful, irreversible physical and emotional scarring,” said Alexa B. Kimball, MD, MPH, lead investigator of the SUNSHINE and SUNRISE trials, Professor of Dermatology at Harvard Medical School, President and CEO of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center, Boston. “This approval marks an important milestone for countless patients who have been faced with limited treatment possibilities and who now have a new option.”

“HS is one of the most devastating and exhausting skin diseases. The pain of flares can be debilitating and limits my ability to work or participate in social activities. It can have a major impact on me physically and emotionally, including feelings of anxiety, stress and isolation,” said Donna Atherton, EdD, Founder and Chief Mission Officer, International Association of Hidradenitis Suppurativa Network (IAHSN). “The approval of a new treatment option brings fresh hope to me and the HS community that we may find relief from the burden of the disease.”

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. 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.

“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. “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.”