Sanofi (NASDAQ: SNY) and Regeneron (NASDAQ: REGN) have jointly created Dupilumab under a global collaboration agreement. The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) gave a green signal to companies’ drug Dupixent® (dupilumab) in the European Union (EU) to include add-on maintenance treatment for children aged 6 to 11 years with severe asthma with type 2 inflammation.
The European Commission is likely to make a final decision on the Dupixent application in the coming months. The green signal of CHMP is supported by Phase III data. According to Phase III data newly released in the New England Journal of Medicine, Dupixent added to standard of care substantially decreases the incidence of severe asthma attacks and rapidly enhanced lung function in children with uncontrolled moderate-to-severe asthma within two weeks, with the sustained improvement of up to 52 weeks.
Furthermore, the trial's safety findings were broadly in line with Dupixent's known safety profile in patients aged 12 and up with mild asthma. Injection site responses, viral upper respiratory tract infections, and eosinophilia were the most prevalent adverse events seen with Dupixent compared to placebo.
In addition, the FDA authorized Dupixent as an add-on maintenance medication for patients over the age of 6 to 11 years with mild-to-critical asthma marked by an eosinophilic phenotype or oral corticosteroid-dependent asthma on October 20, 2021. In the EU, the use of Dupixent in children aged 6 to 11 years with uncontrolled breathing problems is still under evaluation.