Approved: First Rx for Eosinophilic Esophagitis

(RxWiki News) The US Food and Drug Administration (FDA) has approved the first treatment for a rare but serious chronic immune disorder.

The FDA approved Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE) in adults and kids who weigh at least 88 pounds.

EoE is a chronic inflammatory disorder marked by a type of white blood cells called eosinophils being present in the esophagus. The result of this condition is often symptoms like difficulty swallowing, food getting stuck in the esophagus and having trouble eating.

Dupixent, a monoclonal antibody, acts to reduce and prevent the inflammation that causes these symptoms, the FDA said.

Before this approval, patients with this condition had no approved treatment options.

“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.,” said Dr. Jessica Lee, director of the FDA’s Division of Gastroenterology, in a press release. “Today’s approval will fulfill an important unmet need for the increasing number of patients with eosinophilic esophagitis.”

The effectiveness of Dupixent in treating EoE was studied in a placebo-controlled trial. In this trial, only 5 percent of patients who received the placebo (fake treatment) saw their eosinophil levels reduce by the desired amount. For those who received Dupixent, that figure was 60 percent.

Side effects of Dupixent included viral infections, joint pain, upper respiratory tract infections and injection-site reactions. This medication comes with warnings about potential allergic reactions, keratitis, conjunctivitis and joint pain. The FDA noted that Dupixent may not be used in conjunction with live vaccines or in patients with certain parasitic infections.

The FDA approved Dupixent for Regeneron Pharmaceuticals, Inc. This medication was previously approved to treat atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis in certain populations.

Talk to your health care provider about the best available treatments for your condition.