FDA approves first treatment for eosinophilic esophagitis
The monoclonal antibody is indicated to treat the chronic immune disorder in adults and pediatric patients ages 12 years and older who weigh at least 40 kg.
The FDA has approved the first treatment for patients with eosinophilic esophagitis, the agency announced on May 20.
Dupilumab (Dupixent), a monoclonal antibody, is now indicated to treat the chronic immune disorder in adults and pediatric patients ages 12 years and older who weigh at least 40 kg. The drug was originally approved in 2017 to treat moderate-to-severe atopic dermatitis in adult and pediatric patients ages 6 years and older whose disease is not adequately controlled by topical prescription therapies or when those therapies are not advisable.
Efficacy and safety of the drug in treating eosinophilic esophagitis were studied in a randomized controlled trial, which included two 24-week treatment periods. Patients who received the drug had greater reductions of eosinophils in the esophagus and experienced greater improvements in dysphagia symptoms compared to those who received placebo.
The most common side effects associated with the drug include injection-site reactions, upper respiratory tract infections, joint pain, and herpes viral infections. The drug label carries warnings and precautions, including those addressing potential development of allergic reactions, conjunctivitis, keratitis, or joint pain; use in patients with certain parasitic infections; and use in conjunction with live vaccinations.