European Commission approves Cosentyx for adults with hidradenitis suppurativa
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Key takeaways:
- Cosentyx is the first human biologic that directly inhibits interleukin-17A to be approved in any disease.
- The approval was supported by positive results from two phase 3 trials.
The European Commission has approved Cosentyx in the European Union for the treatment of moderate to severe hidradenitis suppurativa in adults who do not respond to conventional therapy, Novartis announced in a press release.
This approval, which follows the European Medicines Agency’s recommendation in April, makes Cosentyx (secukinumab) the first and only human biologic that directly inhibits interleukin-17A and also the first new biologic treatment to be approved in nearly 10 years in this indication.
The European Commission’s decision was supported by results from the phase 3 SUNSHINE and SUNRISE trials in which Cosentyx demonstrated superior efficacy compared with placebo.
Results showed that a significantly greater proportion of patients (> 55%) receiving Cosentyx achieved a Hidradenitis Suppurativa Clinical Response at week 52 compared with placebo.
“We are pleased to bring Cosentyx as a much needed and trusted treatment option that brings rapid and sustained symptom relief to HS patients,” Haseeb Ahmad, president of Novartis in Europe, said in the release. “With established market access and patient support programs, Novartis is in a strong position to support fast and widespread access to Cosentyx.”
Later this year, the company anticipates a regulatory decision from the FDA.
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