FDA approves first treatment for eosinophilic esophagitis in the US
Click Here to Manage Email Alerts
The FDA has granted approval for dupilumab for the treatment of eosinophilic esophagitis for adult and pediatric patients aged 12 years and older, according to a press release.
Dupilumab (Dupixent, Sanofi; Regeneron Pharmaceuticals, Inc.) is the first drug in the U.S. specifically indicated for the treatment of this condition.
“It is very exciting that we now have the first FDA-approved treatment option specifically for patients with eosinophilic esophagitis, and one that is targeted to an underlying cause of this disease,” Evan Dellon, MD, professor of medicine in the division gastroenterology and hepatology at the University of North Carolina School of Medicine, said. “Treatment for patients with eosinophilic esophagitis can be challenging, particularly with no previously approved medications. Now, patients and their doctors have a treatment option available as part of their management plan that has the potential to control symptoms, improve inflammation, and heal the changes in the esophagus caused by this progressive and burdensome disease.”
Researchers evaluated the safety and efficacy of the drug in a randomized, double-blind, parallel-group, multicenter, placebo-controlled trial. The research included two separate 24-week treatment periods which were labeled part A and part B.
The two primary efficacy measures were the proportion of patients who achieved a pre-determined level of reduced eosinophils in the esophagus at 24 weeks and a change in Dysphagia Symptom Questionnaire (DSQ) score from baseline to 24 weeks.
In part A of the trial, 60% of patients receiving dupilumab achieved the pre-determined level of reduced eosinophils, with an average improvement of 22 points in their DSQ score. In part B, 59% of patients recieving dupilumab achieved the pre-determined level of reduced eosinophils, with an average improvement of 24 points in their DSQ score.
The most common reported side effects included injection site reactions, upper respiratory tract infections, joint pain and herpes viral infections.
Perspective
Back to Top
Dupilumab is the first FDA-approved medication for eosinophilic esophagitis. While there are other effective options for EoE, including food elimination diets, proton pump inhibitors and topical corticosteroids, this certainly is an exciting therapy option.
In a randomized, controlled trial, researchers showed that dupilumab significantly reduced eosinophils and improved symptoms compared with placebo. We do not have studies comparing dupilumab with other treatment options.
Dupilumab is a weekly injection that is, overall, considered safe but some common side effects include injection site reactions and upper respiratory infections.
Read more about
Click Here to Manage Email Alerts