Novartis’s Cosentyx Received the US FDA’s Approval for the Treatment of Hidradenitis Suppurativa
Shots:
- The approval was based on 2 P-III studies (SUNSHINE) & (SUNRISE) evaluating the short (16wks.) & long-term (52wks.) efficacy, safety & tolerability of Cosentyx (IL-17A inhibitor, 300mg) vs PBO in 2 cohorts of patients (n=≥1,000) with moderate to severe HS. The 1EPs of both the study were HiSCR50
- The short-term results depicted that 44.5% & 38.3% of patients receiving doses at Q2W achieved HiSCR50 vs 29.4% & 26.1% whereas at Q4W the responses were seen in 41.3% & 42.5% vs 29.4% & 26.1%
- In addition, the 52wks. extended study of these patients showed an enhanced HiSCR50 response in both trials, with 65.0% & 62.2% responses in the (SUNRISE) trial and 56.4% & 56.3% responses in the (SUNSHINE) trial at dosing Q2W & Q4W
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