FDA Approves Cosentyx for HS
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.
The US Food and Drug Administration (FDA) has given its nod to Novartis’ Cosentyx (secukinumab) to treat moderate to severe hidradenitis suppurativa (HS) in adults. The IL-17A inhibitor is the first new biologic treatment option for HS patients in nearly a decade.
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.
“This approval is a huge milestone for so many patients with HS who have had limited treatment options and were suffering from the immense impact of HS on quality of life,” says Jennifer Hsiao, MD, a Clinical Associate Professor of Dermatology at the University of Southern California (USC) in Los Angeles.
Humira (adalimumab) is approved to treat HS, but not all patients can take TNF inhibitors. “ I am so excited to have a second FDA-approved medication to treat patients with and help them access,” Dr. Hsiao tells DermWire.
Of note, the Cosentyx HS approval allows for a flexible dosing regimen which is a huge plus, she says.
“Finally! we have been waiting for this for so long,” agrees Adam Friedman, MD, professor and chair of dermatology at George Washington University in Washington, DC. “HS is a common chronic inflammatory disease that disrupts every aspect of a patients life and having the second FDA approved option which specifically targets the underpinning of this disease is a welcome addition.”
The FDA approval was based on analyses from 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.
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.
HS experts react to approval of Cosentyx
"This approval marks an important milestone for countless patients who have been faced with limited treatment possibilities and who now have a new option," says 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, in a news release.
"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," says 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."
“It is a thrilling development that Cosentyx is now FDA-approved for HS. It has been a long time coming," says Christopher G. Bunick, MD, PhD, an Associate Professor of Dermatology at Yale University School of Medicine in New Haven, Conn. "Hidradenitis suppurativa is a devastating disease for patients that have moderate to severe activity, and having another FDA approved biologic, besides Humira, is incredibly important to give patients options," he tells DermWire. "As we have learned from psoriasis and atopic dermatitis patients, not all patients respond to a single therapy. Giving HS patients another powerful option to try to limit and control disease activity is essential to them regaining quality of life."
The FDA approval should mean more insurances will cover this important therapeutic option for HS patients, he says.. "This is a major step forward for HS patients and their providers.“
Haley B. Naik, MD, agrees. She is an Associate Professor of Dermatology at University of California, San Francisco. "The approval of secukinumab is a win for HS patients," Dr. Naik tells DermWire. "Patients now not only have a second option for approved therapy for HS, but also an option that raises the bar for what we can expect from therapeutic response. I am excited to see a novel therapy that improves HS and quality of life for patients make it through the regulatory pipeline."