According to the companies, Dupixent, a medication from Sanofi (NASDAQ:SNY) and Regeneron Pharmaceuticals (NASDAQ:REGN), has been shown to be effective and safe in asthmatic children aged six to eleven years old for up to two years.
Dupixent (dupilumab) was assessed in phase 3 open-label extension trial as a maintenance treatment. In 365 children aged 6 to 11 years with uncontrolled moderate-to-severe asthma and indications of type 2 inflammation, Dupixent combined with other asthma drugs showed efficacy and safety that was consistent for up to two years, according to Sanofi in a news statement on September 5.
Compared to the pivotal trial baseline, children treated with Dupixent had a lower incidence of severe asthma episodes, with an average of 0.118–0.124 incidents per year as opposed to 2.16-2.56 events per year. According to Sanofi, the kids’ lung function continued to improve over the course of the pivotal study, increasing by 9.43 to 12.6 percentage points from baseline at 52 weeks.
In addition, after two weeks, children who switched from placebo in the pivotal study to Dupixent in the extension trial experienced an 8.71 percentage point improvement in lung function. Adverse event rates ((AEs)) were 61-68% overall. The businesses said that the most frequent adverse events (AEs) (5%) included nasopharyngitis (9–10%), pharyngitis (6–10%), upper respiratory tract infection (4–8%), and influenza (5–6%).
The trial’s safety findings were in line with Dupixent’s acknowledged safety profile for use in approved respiratory applications. The overall rates of adverse events (AEs) during the 52-week treatment term ranged from 61-68%. Nasopharyngitis (9–10%), pharyngitis (6–10%), upper respiratory tract infection (4–8%), influenza (5–6%), eosinophilia (3-6%), allergic rhinitis (3–7%), diarrhea (4-6%), and injection site reactions (3–7%) were the most frequent adverse events (AEs; 5%).
In a deal that included an upfront $900 million payment back in June, Regeneron purchased worldwide rights to the cancer medication Libtayo from Sanofi SA (SASY.PA).
This was in line with the 2015 collaboration agreement, where Sanofi/Regeneron jointly marketed the drug in the US while Sanofi was in charge of export sales. Libtayo’s global revenues were distributed equitably.
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