The First! Blockbuster Anti-inflammatory Drugs Gain New Indications

On May 21, the U.S. FDA announced that it approved the expanded indication of Dupixent (dupilumab), a blockbuster IL-4/IL-13 inhibitor jointly developed by Sanofi and Regeneron, for the treatment of eosinophilia Esophagitis (EoE) in adults and pediatric patients over 12 years (weight at least 40 kg). The press release notes that this is the first FDA-approved therapy for EoE.

Eosinophilic esophagitis is a chronic, progressive type 2 inflammatory disease that damages the esophagus, preventing it from working properly. Sometimes swallowing even a small amount of food or taking a sip of water can cause pain and a blocked esophagus. In severe cases, feeding tubes are the only means of maintaining normal energy intake and weight gain. People with eosinophilic esophagitis often have poor quality of life and are more likely to experience depression.

Dupixent is a fully humanized monoclonal antibody that inhibits the signaling of IL-4 and IL-13 proteins. Data from the Dupixent clinical trial suggest that IL-4 and IL-13 are key drivers of type 2 inflammation, which plays a role in inflammatory diseases such as asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), and atopic dermatitis important role. Dupixent has been granted Breakthrough Therapy Designation by the FDA for the treatment of eosinophilic esophagitis. Less than two months ago, the FDA granted it Priority Review status for a supplemental Biologics License Application for the treatment of eosinophilic esophagitis.

FDA approval is based on the results of a Phase 3 clinical trial consisting of two parts (A and B). Trial results showed that in patients receiving Dupixent, after 24 weeks of treatment, patients in Parts A and B had a 69% and 64% reduction in disease symptoms, respectively, compared to baseline. The values in the placebo group were 32% and 41%, respectively.

About 10 times as many patients in the Dupixent group achieved histological disease remission as those in the placebo group.

In terms of safety, the safety profile of Dupixent is similar to the approved indications. The most common adverse events are injection site reactions, upper respiratory tract infection, arthralgia and herpes virus infection.

“Eating regularly throughout the day is essential, however difficulty swallowing food is a common symptom for people with eosinophilic esophagitis. This often leads to fear of pain and esophageal obstruction at every meal of the day. Our 3 A Phase 1 clinical development program has shown that weekly Dupixent use improves swallowing ability and reduces inflammation in the esophagus. This is a landmark approval for patients and their caregivers, bringing a new treatment option to them."