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Sanofi-Regeneron Tout New Data For Dupixent From Pediatric Asthma Trial

Sanofi-Regeneron Tout New Data For Dupixent From Pediatric Asthma Trial
  • Sanofi SA (NASDAQ: SNY) and Regeneron Pharmaceuticals Inc (NASDAQ: REGN) have unveiled detailed results from a Phase 3 trial evaluating Dupixent (dupilumab) in children aged 6 to 11 years for the treatment of asthma.
  • In a phase 3 trial called Voyage, Dupixent plus standard-of-care asthma therapy significantly cut asthma attacks at Week 24 and improved lung function within two weeks in children ages 6 to 11 with moderate-to-severe asthma, compared with standard care.
  • Investigators tested the drug in 408 children, dividing them into two groups, each with different markers of type 2 asthma.
  • The Dupixent patients saw an improvement in asthma control at Week 24 as measured on a 0 to 6 scale of symptom severity and disease impact.
  • The two groups of Dupixent patients reported score improvements of 1.33 and 1.44 on the scale, respectively, compared with 0.88 and 1.00 for those on placebo.
  • The improvement for patients on Dupixent more than doubled the "clinically meaningful threshold of 0.5 points," Sanofi said.
  • There was a significant reduction in mean FeNO levels (airway biomarker), to below the threshold for type 2 inflammation, which is 20 parts per billion (ppb).
  • Patients taking Dupixent had an average improvement in FeNO levels by -20.59 and -17.84 ppb vs. placebo from baseline to week 12 (p<0.0001 for both values).
  • Price Action: REGN shares closed 1.5% higher at $523.73, and SNY shares are 1.42% higher at $53.49 during the market session on the last check Monday.

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Posted-In: asthma Briefs Phase 3 TrialBiotech News Health Care FDA General

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