FDA approves secukinumab for adults with HS

The U.S. Food and Drug Administration (FDA) has approved secukinumab for the treatment of adults with moderate to severe hidradenitis suppurativa (HS).

This development, announced today, makes secukinumab the first and only interleukin (IL)-17A inhibitor approved by the FDA for the treatment of HS, which affects approximately 1% of the global population. It joins adalimumab, a TNF blocker, as the only FDA-approved treatment option for HS.

Secukinumab (Cosentyx) has already been approved by the FDA for the treatment of moderate to severe plaque psoriasis in adults, as well as for several other indications, including psoriatic arthritis and ankylosing spondylitis.

Approval for HS was based on the pivotal phase 3 SUNSHINE and SUNRISE trials, which enrolled more than 1,000 HS patients across 40 countries. The studies evaluated the effectiveness, safety and tolerability of two dosing regimens of the drug in adults with moderate to severe HS at 16 weeks and up to 52 weeks.

According to a Novartis press release announcing the approval, results at week 16 showed that a significantly higher proportion of patients achieved clinical response for hidradenitis suppurativa (HiSCR) when treated with secukinumab 300 mg every 2 weeks compared to placebo: 44.5% versus 29.4%. , respectively, in the SUNSHINE trial and 38.3% versus 26.1% in the SUNRISE trial (P. < 0.05 for both associations).

Similarly, results at week 16 showed that a significantly higher proportion of patients achieved HiSCR when treated with secukinumab 300 mg every 4 weeks compared to placebo: 41.3% versus 29.4% in the SUNSHINE trial and 42.5% versus 26.1% in the SUNRISE trial (P. < 0.05 for both associations).

Additionally, in an exploratory analysis spanning 52 weeks, HiSCR values ​​observed at week 16 after either secukinumab dosing regimen improved over time through week 52. In SUNSHINE, the values ​​improved by 56.4% in patients treated with secukinumab every 3 weeks. and 56.3% in those treated with secukinumab every 4 weeks. In SUNRISE, values ​​improved by 65% ​​in patients treated with secukinumab every 2 weeks and by 62.2% in those treated with the drug every 4 weeks.

In an interview, Haley Naik, MD, a dermatologist who directs the hidradenitis suppurativa program at the University of California, San Francisco, called the approval a victory for HS patients. “Patients now have not only a second option for an approved treatment for HS, but also an option that raises the bar for what we can expect from a therapeutic response,” said Dr. -she declared to the press agency. “I am excited to see a new therapy that improves HS and patients’ quality of life move through the regulatory process.”

Naik revealed that she received a grant from AbbVie; consulting fees from 23andme, AbbVie, Aristea Therapeutics, Nimbus Therapeutics, Medscape, Sonoma Biotherapeutics, DAVA Oncology, Boehringer Ingelheim, Union Chimique Belge (UCB) and Novartis; Pfizer investigators’ fees; and owns stock in Radera, Inc. She is also an associate editor of JAMA Dermatology and a board member of the Hidradenitis Suppurativa Foundation.

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