The first pharmaceutical for eosinophilic esophagitis approved in the U.S.

“As researchers and clinicians have gained knowledge about eosinophilic esophagitis in recent years, more cases of the disorder have been recognized and diagnosed in the U.S.”, Jessica Lee of the FDA’s Department of Gastroenterology said in a press release.

Eosinophilic esophagitis is a long-term inflammation of the oesophagus that causes difficulty swallowing. The incidence in Sweden is 7.7 per 100,000 inhabitants a year, affecting about three times as many men as women, according to a review article in Läkartidningen. The current pharmacological treatment uses topically acting corticosteroids or proton pump inhibitors such as omeprazole.

The newly approved drug Dupixent is a monoclonal antibody that partially blocks inflammatory signalling pathways. The drug was previously approved in the U.S. and within the EU for other indications, including against atopic dermatitis.

The marketing authorisation for the treatment with the drug against eosinophil esophagitis has been granted to the American pharmaceutical company Regeneron Pharmaceuticals.