Novartis has announced that the U.S. Food and Drug Administration (FDA) has approved Cosentyx® (secukinumab) for the treatment of moderate-to-severe hidradenitis suppurativa (HS) in adults.
Cosentyx is the first interleukin-17A inhibitor approved for the treatment of HS and is now the second biologic approved to treat the same. It has been 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 FDA approval is based on the SUNSHINE and SUNRISE multicenter, randomized, double-blind, placebo-controlled phase 3 trials. In both trials, a larger proportion of patients who were treated with Cosentyx 300 mg every two weeks achieved at least a 50% decrease in abscess and inflammatory nodule count as determined by the Hidradenitis Suppurativa Clinical Response (HiSCR50) compared to placebo (SUNSHINE 44.5% vs 29.4% and SUNRISE 38.3% vs 26.1%). Furthermore, a greater proportion of patients randomized to Cosentyx 300 mg who were dosed every four weeks (after being given the standard weekly loading doses) achieved HiSCR50 in both SUNSHINE (41.3% vs 29.4%) and SUNRISE (42.5% vs 26.1%) trials compared with placebo.
According to Novartis’ press release, “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.”
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 has stated, “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. This approval marks an important milestone for countless patients who have been faced with limited treatment possibilities and who now have a new option.”