Sanofi – Aventis Groupe of Sanofi (SNYNF,SNY) announced Monday that late-breaking Dupixent (dupilumab) data showed consistent efficacy and safety profile for up to two years in children aged 6 to 11 years with moderate-to-severe asthma.
The results from the longest global Phase 3 open-label extension trial in this age group in asthma showed sustained improvement in lung function, low rate of asthma attacks and a consistent safety profile for up to two years.
The results are from data in children who entered the extension trial after finishing active treatment or placebo in the Phase 3 trial (pivotal trial). Children in the extension trial were treated for up to an additional year with Dupixent, providing up to two years of data in total.
The data demonstrated the efficacy and safety profile of Dupixent (dupilumab) as a maintenance therapy when added to other asthma medications.
These results were presented in a late-breaking session at the 2022 European Respiratory Society or ERS International Congress. More than 500,000 people around the world have been treated with Dupixent in its approved indications.
Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation.
In the EU, Dupixent is approved in children aged 6 to 11 years as an add-on maintenance treatment for severe asthma with type 2 inflammation.
Dupixent has received regulatory approvals around the world for use in certain patients with atopic dermatitis, asthma, CRSwNP or EoE in different age populations.
Dupixent is currently approved across these indications in the U.S. and for one or more of these indications in more than 60 countries, including in the European Union and Japan.
Source: Read Full Article