Skip to NavigationSkip to content

FDA accepts Dupixent for Priority Review in patients 12+ with eosinophilic esophagitis

Published on 04/04/22 at 10:16am

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.

Lina Adams

Mission Statement is a leading portal for the pharmaceutical industry, providing industry professionals with pharma news, pharma events, pharma service company listings and pharma jobs,
Site content is produced by our editorial team exclusively for and our industry newspaper Pharmafocus. Service company profiles and listings are taken from our pharmaceutical industry directory, Pharmafile, and presented in a unique Find and Compare format to ensure the most relevant matches