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news.Sanofi and Regeneron Pharmaceuticals have secured breakthrough therapy status from the US Food and Drug Administration (FDA) for Dupixent (dupilumab) to treat patients 12 years and older with eosinophilic esophagitis (EoE).
The US FDA’s Centre for Drug Evaluation and Research. (Credit: The U.S. Food and Drug Administration)
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Dupixent, a fully-human monoclonal antibody, blocks the signalling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins.
The regulator has provided breakthrough therapy device designation based on data from part A of a phase 3 trial in patients with EoE.
Sanofi stated that there are no FDA-approved medicines are currently available for EoE, a chronic and progressive type 2 inflammatory disease that impairs the esophagus and disturbs it from working efficiently.
Part A of the randomised, double-blind and placebo-controlled trial of 81 patients is said to achieve both of its co-primary endpoints and all major secondary endpoints.
Part A of the trial also showed safety results in line with the known safety profile of Dupixent in its approved indications.
The ongoing EoE trial is currently recruiting additional patients in part B and includes patients continuing in a 28-week extended active treatment period (Part C) after completing either Part A or Part B.
At present, the potential use of Dupixent in EoE is under clinical development, and its safety and efficacy for this indication were not assessed by any regulatory authority.
Dupixent has already secured FDA approval to treat patients aged six years and older with moderate-to-severe atopic dermatitis, which is not efficiently controlled with prescription therapies used on the skin or who cannot use topical therapies.
It is also approved for use with other asthma medicines for the maintenance treatment of moderate-to-severe eosinophilic or oral steroid-dependent asthma in patients aged 12 years and older whose asthma is not controlled with their current asthma medicines.
Earlier this month, French pharmaceutical firm Sanofi and British drugmaker GlaxoSmithKline (GSK) have commenced the phase 1/2 clinical of the Covid-19 adjuvanted recombinant protein-based vaccine candidate.
