The US Food and Drug Administration (FDA) has accepted Regeneron Pharmaceuticals and Sanofi’s Dupixent (dupilumab) supplemental Biologics License Application (sBLA) for priority review.
Upon receiving approval, the human monoclonal antibody Dupixent will be the first medicine available in the US for the treatment of eosinophilic esophagitis (EoE).
It is designed to inhibit the signalling of interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways.
The application is for the treatment of EoE in patients aged 12 years and above with a drug dose of 300mg that will be given weekly.
Regeneron and Sanofi expect a decision on approval for the investigational use of the drug from the regulatory agency on 3 August this year.
The regulatory application was supported by data obtained from two Phase III trials as well as data from an active long-term extension trial.
These two studies assessed Dupixent’s safety and efficacy in EoE patients aged 12 years and above.
Compared to placebo, dupilumab at 24 weeks significantly improved signs and symptoms of EoE.
It also improved the ability to swallow and reduced eosinophil counts in the esophagus.
In the two trials, the safety results were similar to Dupilumab’s safety profile in its already approved indications.
The injection site reactions are the most common adverse event observed with the therapy.
Dupixent received Orphan Drug designation in 2017 and Breakthrough Therapy designation from the US FDA in 2020 for the same indication.
Regeneron Pharmaceuticals said in a statement: “Regulatory filings around the world are also planned in 2022. The potential use of Dupixent in EoE is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority.”
The drug has also been approved in the US for several indications, including moderate-to-severe atopic dermatitis, moderate-to-severe asthma characterised by an eosinophilic phenotype or oral corticosteroid-dependent asthma, and chronic rhinosinusitis with nasal polyposis.