Sanofi, Regeneron Dupixent gets approval in EU for expanded use in eosinophilic esophagitis
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The European Commission (EC) approved Sanofi (NASDAQ:SNY) and Regeneron Pharmaceuticals' (NASDAQ:REGN) Dupixent to treat eosinophilic esophagitis (EoE) in patients 12 years and older, weighing at least 40 kg, who are inadequately controlled by, are intolerant to, or who are not eligible for conventional medicinal therapy.
A panel of the European Medicines Agency (EMA) had recommended the expanded approval of the companies blockbuster drug Dupixent (dupilumab) in December 2022.
The French pharma giant said that with this approval, Dupixent is the first and only targeted medicine specifically indicated to treat EoE in Europe and the U.S.
In May 2022, the U.S. FDA approved the expanded use of Dupixent in EoE. Dupixent is now approved to treat five diseases with underlying type 2 inflammation in the EU, according to Sanofi.
The EC decision was backed by data from a phase 3 trial which consisted of three parts.
"With this latest approval for Dupixent, adults and adolescents in the EU suffering from the chronic and often debilitating symptoms of EoE now have the first and only targeted treatment option clinically proven to reduce both esophageal inflammation and damage, as well as improve swallowing ability, pain and health-related quality of life," said Naimish Patel, head of Global Development, Immunology and Inflammation at Sanofi.
EoE is a condition in which a type of white blood cell called eosinophil builds up in the esophagus due to allergic reactions or acid flux. This can inflame or damage esophageal tissue which can cause difficulty in swallowing.