Sanofi/Regeneron Dupixent shows efficacy for up to 2 years in children with asthma
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Sanofi (NASDAQ:SNY) and Regeneron Pharmaceuticals (NASDAQ:REGN) said their medicine Dupixent showed efficacy and safety of up to two years in children aged six to 11 years with asthma.
In the phase 3 open-label extension trial, Dupixent (dupilumab) was evaluated as a maintenance therapy. Dupixent added to other asthma medications showed efficacy and safety which was consistent for up to two years in 365 children aged 6 to 11 years with uncontrolled moderate-to-severe asthma with evidence of type 2 inflammation, Sanofi said in a Sept. 5 press release.
Children treated with Dupixent experienced a low rate of severe asthma attacks with an average of 0.118-0.124 events per year, compared to 2.16-2.56 events per year at baseline in the pivotal trial.
Sanofi added that the children also had sustained improvement in lung function at 52 weeks, of 9.43-12.6 percentage points from baseline in the pivotal trial.
In addition, children who switched from placebo in the pivotal trial to Dupixent in the extension trial showed improvement of 8.71 percentage points in lung function at two weeks.
The overall rates of adverse events ((AEs)) were 61-68%. The most common AEs (â¥5%) were nasopharyngitis (9-10%), pharyngitis (6-10%), upper respiratory tract infection (4-8%) and influenza (5-6%), among others, the company noted.