The European Commission approved Sanofi (SAN.PA) and Regeneron Pharmaceuticals' (RGO.F, REGN.VI) Dupixent as the first targeted therapy for children aged two to 11 years with moderate-to-severe chronic spontaneous urticaria.
The authorization extends the existing approval of Dupixent, or dupilumab, in the European Union for chronic spontaneous urticaria, an inflammatory skin condition characterized by "sudden and debilitating hives and recurring itch," according to a Monday release. The previous indication was for patients 12 years and older.
The approval was supported by data from the Liberty-Cupid clinical program, which combined an extrapolation of efficacy data in adults from two late-stage studies and pediatric data from the CUPIDKids phase 3 study. CUPIDKids was a single-arm study that evaluated children with chronic spontaneous urticaria between two years old and 11 years old who were still symptomatic even with the use of antihistamines.
The trials showed that Dupixent significantly outperformed placebo in reducing hives and itching by the 24-week mark, while also increasing the number of patients achieving a complete response. Across all studies, the safety profile remained consistent with Dupixent's safety results in other skin-related indications.
"Young children suffering from chronic spontaneous urticaria often experience an unpredictable barrage of unrelenting itch and visible hives during the critical years of their growth and development. As the first and only targeted medicine for young children in the EU with CSU, Dupixent has the potential to become the new standard of care for those who remain symptomatic despite other available treatments," Regeneron President and Chief Scientific Officer George D. Yancopoulos said.
The US Food and Drug Administration is currently reviewing a supplemental biologics license application for Dupixent in the US for pediatric patients aged two to 11 years for chronic spontaneous urticaria. The treatment is already approved for the same indication in certain adults and teenagers in the US, Japan, and other countries.
Approved in over 60 countries, Dupixent treats various type 2 inflammatory conditions, including asthma, chronic obstructive pulmonary disease, and atopic dermatitis, among others. Sanofi and Regeneron are also evaluating dupilumab in diseases such as chronic pruritus of unknown origin and lichen simplex chronicus.
Sanofi's shares were down over 1% in Paris, while Regeneron's stocks listed in Frankfurt and Vienna were marginally higher by Monday midday.