Sanofi/Regeneron presents full data of Dupixent efficacy in skin disease prurigo nodularis
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Sanofi (NASDAQ:SNY) and Regeneron Pharmaceuticals (NASDAQ:REGN) on Sept. 8 reported detailed results from a phase 3 trial showing that Dupixent significantly reduced itch and skin lesions at 24 weeks in in adults with uncontrolled prurigo nodularis (PN).
The company presented detailed results from one of two pivotal phase 3 trials, dubbed PRIME, at the European Academy of Dermatology and Venereology (EADV) 2022 Congress.
PN a skin disease which causes hard, itchy lumps (nodules) to form on the skin.
At 24 weeks, among patients treated with Dupixent (dupilumab) 60% experienced a clinically meaningful reduction in itch from baseline, the main goal of the study compared to 18% of patients on placebo, Sanofi said.
The French pharma giant added that 48% of those on Dupixent achieved clear or almost clear skin, a key secondary goal, compared to 18% of patients on placebo.
The safety dat of the study was generally consistent with the known safety profile of Dupixent, the company noted.
Overall rates of adverse events (AEs) were 71% for Dupixent and 63% for placebo. AEs most commonly seen with Dupixent (â¥5%) included nasopharyngitis (5% Dupixent, 4% placebo) and headache (5% Dupixent, 5% placebo).
Sanofi said there are currently no approved drugs specifically for PN and Dupixent is currently under review in the U.S. and EU.