- Regeneron Pharmaceuticals (REGN +0.4%) and Sanofi (SNY +1.0%) announce detailed results from a Phase 3 trial in which Dupixent (dupilumab) significantly reduced severe asthma attacks, and improved lung function in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma, with evidence of type 2 inflammation.
- Dupixent also significantly improved overall asthma symptom control and reduced an airway biomarker of type 2 inflammation that plays a major role in asthma, called fractional exhaled nitric oxide ((FeNO)).
- The Phase 3, randomized, double-blind, placebo-controlled VOYAGE trial evaluated the efficacy and safety of Dupixent (100 mg or 200 mg every two weeks, based on weight) combined with standard-of-care asthma therapy in 408 children with uncontrolled moderate-to-severe asthma.
- The data are being presented at the 2021 American Thoracic Society International Conference ((ATS 2021)).
- The FDA had accepted for review the supplemental Biologics License Application ((sBLA)) for Dupixent (dupilumab) as an add-on treatment for children aged 6 to 11 years with uncontrolled moderate-to-severe asthma, in March.