FDA Approves First Drug for Chronic Disease Eosinophilic Esophagitis
Monoclonal antibody Dupixent was approved after a successful double-blind clinical trial.
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By - Sanofi’s Dupixent received FDA approval for use in people suffering from eosinophilic esophagitis (EoE) after a double-blind, placebo-controlled trial proved the drug effectively reduces eosinophils in the esophagus and improves symptoms of the disease.
Sanofi has had a string of recent pharmaceutical successes, receiving FDA approval for a meningitis vaccine and a comprehensive pediatric inoculation. In partnership with GSK, the company also released its version of a COVID-19 vaccine across Europe.
Results from their recent parallel-group study found that 60% and 59% of patients receiving Dupixent saw an improvement in their EoE, compared to only 5% and 6% of the placebo groups included in the trial. The clinical trial utilized a Dysphagia Symptom Questionnaire designed to measure patients’ ability to swallow.
EoE is a chronic disease that results from an overactive immune system. The condition can lead to pain in the esophagus and trouble swallowing. EoE is considered rare, but its diagnosis is on the rise now that doctors have begun to recognize it more easily. The disease is more common in white males with allergies, and it is often diagnosed using an endoscopy or biopsy of the esophagus.
“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 US,” said Jessica Lee, MD, director of the Division of Gastroenterology in the FDA’s Center for Drug Evaluation and Research. “Today’s approval will fulfill an important unmet need for the increasing number of patients with eosinophilic esophagitis.”
In 2017, the monoclonal antibody was approved to treat atopic dermatitis, and this recent FDA decision is the fourth indication the drug has received approval for.
The approval of Dupixent significantly improves patients’ access to medicine, and it is the first drug approved to treat EoE. Before this approval, no specific medicines were found to consistently improve patients' conditions, and treatments often involved elimination diets.
Dupixent acts in the body by reducing the immune response and blocking specific chemical messengers from binding to cell surfaces. The result is less severe inflammation. The drug is administered via a subcutaneous injection.
The drug was recommended only to patients with moderate or severe atopic dermatitis in the past. Its new indication represents a better understanding of the effectiveness of monoclonal antibodies in treating chronic diseases. Monoclonal antibodies have also been successfully used to treat certain types of cancer like chronic lymphocytic leukemia.
