- Regeneron Pharmaceuticals Inc (NASDAQ: NASDAQ:REGN) and Sanofi (EPA:SASY) 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.
- Related: Sanofi-Regeneron's Flagship Drug Shows Consistent Efficacy, Safety Profile At Two Years For Asthma In Kids.
- 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.
- Price Action: REGN shares are up 19.10% at $710.10, and SNY stock is down 0.74% at $40.17 on the last check Thursday.
Read at Benzinga