Sanofi's Dupixent scores big as the first FDA-approved treatment for eosinophilic esophagitis

Already on a roll, Sanofi and Regeneron’s Dupixent just scored a big FDA win by nabbing a new indication as the first and only medicine approved to treat eosinophilic esophagitis (EoE).

The disease affects more than 160,000 patients in the U.S., who until now have been forced to turn to treatments not specifically approved for the type 2 inflammatory condition.

Dupixent’s new use covers weekly treatment in EoE patients aged 12 and older. It's the drug’s first approval for a gastrointestinal disease among its four indications.

The progressive, chronic disease makes swallowing extremely difficult, causing pain and choking. Inflammation of the esophagus causes it to narrow over time, and patients often avoid swallowing solid food, even in small amounts.

“Every meal becomes a worry,” Sanofi's Naimish Patel, M.D., who leads the company development for immunology and inflammation, said in an interview.

An invasive procedure can open the esophagus if it gets extremely narrowed, but even that isn’t a permanent fix. In severe cases, a feeding tube in the only option to provide caloric intake.

The approval came more than two months ahead of the FDA’s priority review action date.

In a phase 3 trial, 59% to 60% of patients who took Dupixent reached the predetermined level of reduced eosinophils in the esophagus, compared with 5% to 6% of the placebo group.

The next step is awareness. Many people who experience symptoms such as chronic swallowing problems don’t seek out a diagnosis due to the requirement of an endoscopy to diagnose the disease—and because of the limited hope for relief. But with an FDA-approved treatment, Sanofi is hoping to change that, Patel said.

Sanofi has a EoE filing underway at the European Medicines Agency, and it plans submissions in additional countries later this year. A trial for the treatment in the one to 11 age group is ongoing.

Dupixent is additionally approved for use in certain patients with atopic dermatitis, asthma or chronic rhinosinusitis with nasal polyposis. More than 400,000 patients have been treated globally with the drug. Last year, the drug generated full-year sales of 5.25 billion euros (around $6 billion), according to a Sanofi annual report (PDF). Down the line, execs project it will reach more than 13 billion euros annually.