Sanofi has secured the US Food and Drug Administration (FDA) Breakthrough Therapy designation for Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE) in patients aged 12 years and older.
Dupixent is a human monoclonal antibody designed to inhibit the signalling of interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins. The drug is being developed by Sanofi under collaboration with Regeneron.
Regeneron is a biotechnology company engaged in the development of treatments for patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, infectious diseases and rare diseases.
The drug has been approved in the US for several indications, including moderate-to-severe atopic dermatitis, moderate-to-severe eosinophilic or oral steroid-dependent asthma, and chronic rhinosinusitis with nasal polyposis (CRSwNP).
Also, Dupixent is approved in various countries other than the US, including the EU and Japan, to treat moderate-to-severe atopic dermatitis, asthma and severe CRSwNP, in specific patients.
FDA designation for Dupixent is based on the positive results from Part A Phase 3 clinical trial
According to the company, EoE is a chronic and progressive type 2 inflammatory disease that damages the esophagus, affecting the organ’s functioning, and no FDA approved medicines are currently available for the condition.
The French pharmaceutical firm said that the FDA has granted the designation for investigational use, and is based on the positive results from Part A Phase 3 clinical trial, a randomised, double-blind, placebo-controlled clinical trial, evaluating Dupixent in EoE patients.
In the clinical trial, 81 patients met both of its co-primary endpoints, along with all key secondary endpoints. Patients treated weekly with Dupixent 300 mg over 24 weeks experienced a reduction in symptoms, esophageal inflammation and abnormal endoscopic findings in the esophagus.
The Part A study arm also showed safety results, complementing the previously established safety profile of Dupixent in its approved indications.
The company noted that its Dupixent is currently under clinical development, and its safety and efficacy have not been evaluated by any regulatory authority.
