FDA approves Cosentyx as first IL-17A inhibitor for hidradenitis suppurativa
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Key takeaways:
- This approval makes Cosentyx the first interleukin-17A inhibitor and second biologic approved for hidradenitis suppurativa.
- Approval was supported by positive results from SUNSHINE and SUNRISE phase 3 trials.
The FDA has approved Cosentyx for the treatment of adults with moderate to severe hidradenitis suppurativa, Novartis announced in a press release.
The approval makes Cosentyx (secukinumab) the first interleukin-17A inhibitor approved for the treatment of hidradenitis suppurativa (HS) and the second biologic approved for this indication. The drug is approved as a 300 mg dose administered every 4 weeks, with the option to increase to every 2 weeks if the patient is unresponsive.
“Cosentyx can offer effective, lasting relief from HS symptoms so that people with HS have a chance to live every day with confidence,” Victor Bultó, president of Novartis U.S., said in the release. “With this sixth indication approval for Cosentyx — along with ongoing studies in numerous other conditions — we are reaffirming our commitment to reimagine medicine for those living with immunological diseases.”
The approval was based on results from the SUNSHINE and SUNRISE phase 3 trials. At week 16, data showed that an at least 50% decrease in abscess and inflammatory nodule count as determined by Hidradenitis Suppurativa Clinical Response (HiSCR50) was achieved by a higher proportion of patients dosed with Cosentyx 300 mg every 2 weeks compared with placebo in both the SUNSHINE (44.5% vs. 29.4%; P < 0.05) and SUNRISE (38.3% vs. 26.1%; P < 0.05) trials.
A greater proportion of those taking Cosentyx every 4 weeks also achieved HiSCR50 vs. those taking placebo in SUNSHINE (41.3% vs. 29.4%) and SUNRISE (42.5% vs. 26.1%), according to the press release.
Perspective
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The approval of Cosentyx for HS is a huge win for so many patients with HS who have been suffering from this debilitating condition and waiting for new treatment options. HS is a common, chronic, painful inflammatory condition that severely impacts patients’ quality of life.
As a dermatologist who cares for many patients with HS, it is incredibly exciting to have a second FDAapproved medication to discuss with my patients. This approval is a significant step forward for both the HS patient community and their clinician partners!
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