FDA accepts Dupixent for Priority Review in patients 12+ with eosinophilic esophagitis
pharmafile | April 4, 2022 | News story | Sales and Marketing |
The FDA has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab), in patients aged 12 years and older with eosinophilic esophagitis (EoE).
EoE is a chronic and progressive type 2 inflammatory disease that damages the esophagus and impairs the ability to swallow. The disease can also cause narrowing of the esophagus and dilation (physical expansion) of the esophagus may be needed, which is often painful.
The sBLA is supported by data from two Phase III trials evaluating the efficacy and safety of Dupixent 300mg weekly in patients aged 12 years and older with EoE (Part A and Part B), and data from an active long-term extension trial. Dupixent 300mg weekly significantly improved the signs and symptoms of EoE at 24 weeks compared to placebo, including the ability to swallow and reduction in eosinophil count in the esophagus.
In September 2020, the US FDA granted Breakthrough Therapy designation to Dupixent for the treatment of patients aged 12 years and older with EoE. Dupixent was also granted Orphan Drug designation for the potential treatment of EoE in 2017. The potential use of Dupixent in EoE is currently under clinical development, and the safety and efficacy have not yet been fully evaluated by any regulatory authority.
In the US, Dupixent is currently approved in patients aged 6 years and older with uncontrolled moderate-to-severe atopic dermatitis. It is also approved in Europe, Japan, and other countries around the world for use in specific patients with moderate-to-severe atopic dermatitis and certain patients with asthma or CRSwNP in different age populations. It is approved in one or more of these indications in over 60 countries around the world, and over 400,000 patients have been treated globally.