Regeneron Pharmaceuticals Inc (NASDAQ: REGN) and Sanofi SA (NASDAQ: SNY) presented detailed results from the second of two Phase 3 trials (PRIME) evaluating Dupixent (dupilumab) in adults with uncontrolled prurigo nodularis.
Prurigo nodularis patients experience intense, persistent itch with thick skin lesions (nodules) that can cover most of the body.
These data, consistent with the detailed data from the first Phase 3 trial (PRIME2) in prurigo nodularis, show that Dupixent significantly reduced itch and skin lesions at 24 weeks.
At 24 weeks, among patients treated with Dupixent in the trial:
60% of the patients experienced a clinically meaningful reduction in itch from baseline, the primary endpoint, compared to placebo patients (18%).
Nearly three times as many (48%) achieved clear or almost clear skin, a key secondary endpoint, compared to placebo patients (18%).
The safety results of the trial were generally consistent with the known safety profile of Dupixent in its approved dermatological indication.
Regulatory submissions are already under review by the European Commission and the FDA, with the FDA granting a Priority Review and a target action date of September 30.
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