Approved by the US Food and Drug Administration (FDA) Secukinumab For moderate to severe adults Hidradenitis suppurativa (HS).
The development announced today makes secukinumab the first and only interleukin (IL)-17A inhibitor approved by the FDA for HS, which affects an estimated 1% of the world’s population. it is, TNF inhibitor adalimumab as the only FDA-approved treatment option for HS.
Secukinumab (cosentics) was previously approved by the FDA for the treatment of patients with moderate to severe disease. plaque psoriasis Adults, and some other indications psoriatic arthritis and ankylosing spondylitis.
HS approval came under pivotal phase 3 sunlight and sunrise The trial enrolled more than 1,000 HS patients from 40 countries. the study evaluated the efficacy, safety, and tolerability of two dose regimens of this drug from weeks 16 to 52 in adults with moderate to severe HS.
according to press release Novartis announced approval that week 16 results showed that secukinumab 300 mg every two weeks resulted in a significantly higher proportion of patients with hidradenitis suppurativa clinical response (HiSCR) compared to placebo. (44.5% vs. 29.4%, respectively). 38.3% in the SUNSHINE trial and 26.1% in the SUNRISE trial (P < .05 for both associations).
Similarly, week 16 results showed that a significantly higher proportion of patients achieved HiSCR when secukinumab 300 mg was administered every 4 weeks compared to placebo: 41.3% vs. 29.4% in the SUNSHINE trial. , 42.5% vs. 26.1% in the SUNRISE trial (P < .05 for both associations).
Additionally, in an exploratory analysis up to week 52, HiSCR values observed at week 16 after either dose regimen of secukinumab improved over time up to week 52. In SUNSHINE, patients treated with secukinumab every 3 weeks improved by 56.4%. There was a 56.3% increase in patients receiving secukinumab every 4 weeks. In SUNRISE, patients who received secukinumab every 2 weeks improved by 65%, and patients who received secukinumab every 4 weeks improved by 62.2%.
In the interview, Dr. Haley NaikA dermatologist who directs the hidradenitis suppurativa program at the University of California, San Francisco, characterized the approval as a victory for HS patients. “Patients now not only have a second option with an approved treatment for HS, but they also have the option to raise the bar for what they can expect from treatment,” she told the news outlet. . “We are excited to see new treatments moving through the regulatory pipeline that improve HS and patient quality of life.”
Mr. Naik disclosed that he has received grant support from AbbVie. consulting fees from 23andme, AbbVie, Aristea Therapeutics, Nimbus Therapeutics, Medscape, Sonoma Biotherapeutics, DAVA Oncology, Boehringer Ingelheim, Union Chimique Belge (UCB), and Novartis; Investigator fees from Pfizer. She is an associate editor of JAMA Dermatology and a board member of the Hidradenitis Suppurativa Foundation.
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