The approval makes the drug Europe’s first and only IL-17A inhibitor approved for the condition.
The European Commission has approved secukinumab (Cosentyx; Novartis) for the treatment of hidradenitis suppurativa (HS) in adults with moderate to severe disease and a history of inadequate responses to systemic HS therapies, according to a press release1 from Novartis.
Secukinumab is now the first and only approved IL-17A inhibitor approved for HS in the region. It is also the first new biologic treatment approved for HS in almost a decade.
The EC approval comes after positive phase 3 clinical trial datawas released earlier this year from the SUNSHINE and SUNRISE trials. The studies,2 which were identical, double-blind, placebo-controlled, randomized, and took place across 40 different countries, analyzed participants’ clinical responses to secukinumab, as well as the drug’s safety profile over time.
Prospective participants were patients ages 18 and older with a moderate to severe HS diagnosis for at least 1 year prior to the study’s start. Participants also had a history of prior inadequate responses to conventional systemic therapies. Exclusion criteria included a presence of 20 or more fistulae at baseline or had ongoing conditions requiring the use of prohibited medications, such as investigational treatments or systemic biological immunomodulating treatments.
541 patients were screened and approved to participate in the SUNSHINE trial, while 543 were approved to participate in the SUNRISE trial. For 52 weeks, participants received an assigned dose of 300 mg subcutaneous secukinumab administered every 2 weeks, 300 mg subcutaneous secukinumab administered every 4 weeks, or a subcutaneous placebo. Efficacy was defined as the achievement of HS clinical response.
In the SUNSHINE trial, researchers noted that when compared to participants in the placebo group, significantly more patients receiving 300 mg every 2 weeks had a HS clinical response. In the SUNRISE trial, significantly more patients in both secukinumab treatment groups had a HS clinical response compared to patients in the placebo group.
The most common reported adverse event was headache in both trials up to week 16.
“With only one currently approved treatment option, I see HS patients with a tremendous need for alternatives that reduce the disabling physical symptoms of HS, improve the emotional burden and help partially avoid invasive surgery, if treating early,” said Christos Zouboulis in the press release.
Zouboulis is president of the European Hidradenitis Suppurativa Foundation, director of the Departments of Dermatology, Venereology, Allergology and Immunology at Städtisches Klinikum Dessau, and the founding professor of Dermatology and Venereology at the Brandenburg Medical School in Germany.
“This expanded approval offers physicians an additional effective and, for dermatologists, familiar treatment choice that we can feel confident in prescribing for this complex and challenging disease,” he said.
The United States Food and Drug Administration is expected to make regulatory decisions for the drug later in the year.