According to a recent article from WFMZ+, the FDA has recently approved Regeneron’s supplemental Biologics License Application (sBLA) for Dupixent, granting it priority review. Dupixent, also known by the generic name dupilumab, is being developed for eosinophilic esophagitis (EoE) in patients 12 years and older. If approved, it will become the first treatment indicated specifically for EoE patients.

About EoE

Eosinophilic esophagitis (EoE) is a digestive system disorder in which there are high levels of eosinophils in the esophagus. High amounts of these white blood cells typically accumulate when one is exposed to an allergen. Medical professionals have also found that some affected individuals have a high expression of the eotaxin-3 gene, so there may be a genetic component to this condition as well. Regardless of the cause, symptoms include difficulty swallowing, malnutrition, a poor appetite, nausea, vomiting, stomach pain, poor growth, weight loss, and food getting stuck in the throat. In terms of treatment, a change in diet has been proven to greatly improve symptoms. Doctors advise that patients avoid milk, fish, eggs, nuts, soy, and wheat. If one has a very severe case, they may need a liquid diet or steroids to reduce inflammation.

Priority Review for Dupixent

The sBLA was sent to the FDA for weekly doses of 300 mg of Dupixent. The regulatory agency granted approval to the drug, subsequently also granting it Priority Review. Now, the target date for the FDA’s decision is August 3rd of this year.

Approval hinged on data from two clinical trials: Parts A and B of a Phase 3 study focused on the safety and efficacy of Dupixent in EoE patients 12 and older. This was paired with data from an ongoing long-term extension (LTE) trial. Altogether, the following results were produced:

• After 24 weeks, there were significant improvements in EoE signs and symptoms
  • This includes eosinophil count in the esophagus and the ability to swallow
• A consistent safety profile
  • Injection site reactions were the most common adverse event (AE)

In terms of prior designations, Dupixent has already received Orphan Drug and Breakthrough Therapy designations. Looking to the future, global regulatory filings are expected for this year. Hopefully, it receives approval, as it would offer the first approved treatment option for EoE.