FDA Approves Secukinumab for Moderate-to-Severe Hidradenitis Suppurativa

The U.S. Food and Drug Administration (FDA) has granted approval for secukinumab (Cosentyx) to treat adults with moderate-to-severe hidradenitis suppurativa (HS), Novartis announced in a press release today. This makes secukinumab the first interleukin-17A (IL-17A) inhibitor to be approved for HS.

Secukinumab is the second biologic therapy after adalimumab (Humira) to be approved for HS, providing patients with another treatment option for this chronic inflammatory skin condition. HS affects approximately 1% of the global population.

“Today’s approval provides the first IL-17A targeted treatment as a therapeutic option for people living with this chronic, debilitating inflammatory skin disease,” said Victor Bulto, President, Inflammation & Immunology, Novartis Pharmaceuticals Corporation. “At Novartis, we are dedicated to advancing science to address unmet needs and improving lives for patients around the world impacted by immunologic diseases like HS.”

FDA Approval Based on Phase 3 Trial Results

The FDA approval is supported by data from the pivotal Phase 3 SUNSHINE and SUNRISE trials, which evaluated the safety and efficacy of two dosing regimens of secukinumab in adults with moderate-to-severe HS.

More than 1,000 HS patients across approximately 40 countries were enrolled in the two trials. Participants were randomly assigned to receive secukinumab 300 mg or placebo, administered subcutaneously either every week (SUNRISE trial) or every two weeks (SUNSHINE trial) after initial dosing.

Both studies met their primary endpoint, demonstrating that a significantly higher proportion of patients achieved Hidradenitis Suppurativa Clinical Response (HiSCR) with secukinumab versus placebo at 16 weeks.

HiSCR is defined as a 50% or greater reduction in total abscess and inflammatory nodule count, with no increase in abscess or draining fistula count relative to baseline.

In SUNSHINE, HiSCR at week 16 was achieved by 44.5% of patients receiving secukinumab 300 mg every two weeks compared to 29.4% with placebo (p<0.05).

Similarly, in SUNRISE, 38.3% of secukinumab patients reached HiSCR at week 16 versus 26.1% with placebo (p<0.05).

The higher HiSCR rates with secukinumab compared to placebo were sustained over one year of treatment. Exploratory analysis up to 52 weeks showed continued improvement in HiSCR, reaching 56.4% and 56.3% in the two dosing groups in SUNSHINE and 65% and 62.2% in SUNRISE.

Secukinumab Demonstrated Favorable Safety Profile

Secukinumab also exhibited a favorable safety profile after 52 weeks of treatment, with a low rate of candida infections. The most common adverse events were nasopharyngitis, headache, diarrhea, and nausea.

“The safety profile was consistent with the well-established profile of Cosentyx with more than 280,000 patients treated over 10 years across approved indications,” said Bulto.

HS is a chronic, inflammatory skin condition that causes painful abscesses and scarring on the skin. It most commonly affects the underarms, groin, and anal regions, causing considerable pain and discomfort.

“Despite standard of care, there continues to be an unmet need for more effective and better tolerated treatments for this debilitating chronic inflammatory skin disease,” said Bulto. “We thank the patients, investigators and health authorities who have helped make this approval possible.”

First Biologic Therapy Targeting IL-17A Pathway

Secukinumab works by selectively binding and neutralizing IL-17A, a naturally occurring cytokine involved in normal inflammatory responses. However, excessive amounts of IL-17A are believed to play a role in driving inflammatory diseases like HS.

By inhibiting IL-17A, secukinumab helps regulate inflammation and calm overactive immune responses that drive HS symptoms.

“This approval provides patients access to a completely novel mechanism of action to treat HS,” said Dr. Haley Naik, Director of the Hidradenitis Suppurativa Program at UC San Francisco.

“Targeting IL-17A provides an alternative to anti-TNF biologics by utilizing a key cytokine directly involved in HS immunopathogenesis,” explained Dr. Naik.

Secukinumab is the first IL-17A inhibitor to be approved, offering an alternative mechanism of action compared to adalimumab, which blocks TNF-alpha.

Having therapeutic options with different mechanisms of action is important for helping patients who do not respond adequately to or cannot tolerate currently available treatments.

Experts Welcome New Option for Patients

“I’m excited to see a novel therapy that improves hidradenitis suppurativa and quality of life for patients make it through the regulatory pipeline,” said Dr. Naik.

“Patients now not only have a second approved treatment option, but an option that raises the bar for what we can expect from therapeutic response,” she added.

Dr. Naik noted that the large, international and geographically diverse populations studied in the Phase 3 trials support the generalizability and clinical meaningfulness of the findings.

“The results indicate robust efficacy with a safety profile consistent with secukinumab’s known effects,” said Dr. Naik. “Having more approved treatments for this devastating disease is crucial for serving our patients.”

Other experts also welcomed the FDA decision. “Secukinumab shows exciting efficacy in HS patients who previously had limited approved biologic options,” said Dr. Iltefat Hamzavi, Director of the Multidisciplinary HS Clinic at Henry Ford Health System in Detroit.

“Dermatologists treating HS patients will be eager to gain experience with this promising new targeted therapy,” he said.

Dosing and Administration

Secukinumab was approved for HS at a dose of 300 mg given as subcutaneous injection at weeks 0, 1, 2, 3, and 4, followed by monthly maintenance dosing starting at week 8.

Secukinumab is also approved to treat moderate-to-severe plaque psoriasis, active psoriatic arthritis, and active ankylosing spondylitis. For these conditions, it is administered at a dose of 300 mg every four weeks after initial loading doses.

Novartis plans to make secukinumab available to appropriate patients in the coming months. The company also offers patient support programs to help patients access treatment and have a positive treatment experience.