The U.S. Food and Drug Administration approved Sanofi’s Dupixent (dupilumab) 300 mg weekly to treat patients with eosinophilic esophagitis (EoE) aged 12 years and older, weighing at least 40 kg. With this approval, Dupixent is the first and only medicine specifically indicated to treat EoE in the United States.

The U.S. Food and Drug Administration accepted for Priority Review the supplemental Biologics License Application for Dupixent (dupilumab) 300 mg weekly to treat adult and pediatric patients aged 12 years and older with eosinophilic esophagitis (EoE), a chronic and progressive type 2 inflammatory disease that damages the esophagus and impairs the ability to swallow.

Regeneron Pharmaceuticals and Sanofi’s anti-inflammatory drug Dupixent (dupilumab) has shown to be effective against five types of type 2 inflammations, with more indications expected to surface soon. 

Shares of Takeda Pharmaceutical fell after the company announced the U.S. Food and Drug Administration rejected the New Drug Application for TAK-721 (budesonide oral suspension) for the treatment of eosinophilic esophagitis.

Sanofi

Dupixent (dupilumab) scored the blockbuster medicine’s second study win in a week after Regeneron Pharmaceuticals and Sanofi revealed positive results from the second Phase III trial for the treatment of eosinophilic esophagitis (EoE). 

The U.S. Food and Drug Administration approved self-administration of AstraZeneca’s asthma treatment Fasenra which uses a pre-filled, single-use auto-injector pen.

The U.S. Food and Drug Administration approved Regeneron Pharmaceuticals Inc. and Sanofi SA’s drug Dupixent to treat nasal polyps, marking the third major use for the injectable medicine.

The U.S. Food and Drug Administration approved expanded use of Regeneron Pharmaceuticals Inc. and Sanofi SA’s eczema drug Dupixent to include patients aged between 12 and 17 years.

Aimmune Therapeutics said on Monday it would collaborate with Regeneron Pharmaceuticals and Sanofi to develop its experimental peanut allergy drug.