Sanofi, Regeneron get Dupixent EC approval for eosinophilic esophagitis

French pharmaceutical company Sanofi and Regeneron, an American biotechnology company, have received the approval of the European Commission (EC) to market their Dupixent (dupilumab) injection in the European Union for eosinophilic esophagitis (EoE).

Dupixent is indicated in adults and adolescents 12 years and over, who are not candidates for conventional medicinal treatment.

With the approval, Dupixent is now an option for around 50,000 adults and adolescents with severe uncontrolled eosinophilic esophagitis in the European Union and is now indicated for five diseases with underlying type 2 inflammation in Europe.

Dupixent EC approval was backed by the 52-week data from a phase 3 clinical trial, consisting of three parts. In the late-stage clinical trial, around 60% of patients aged 12 years and over treated with Dupixent 300 mg weekly demonstrated histological disease remission and substantially improved their swallowing ability compared to placebo.

George D Yancopoulos — Regeneron President and Chief Scientific Officer, commenting on Dupixent EC approval, said: “This latest approval establishes Dupixent as the only targeted medicine specifically indicated for eosinophilic esophagitis in the European Union.

“Dupixent is also the only biologic shown in pivotal trials to help patients achieve histological remission, reduce difficulty swallowing and improve health-related quality of life – all of which are crucial to reducing the burden of this debilitating disease.

“Since its first approval, Dupixent has redefined the treatment of certain chronic diseases with underlying type 2 inflammation and is now indicated for five conditions in the European Union.”

Available as both a pre-filled pen and prefilled syringe, Dupixent is an injection administered under the skin at a dosage of 300 mg every week.

Sanofi and Regeneron are jointly developing Dupilumab under a global collaboration agreement.

Dupixent has been approved in many countries for use in different age patients with atopic dermatitis, chronic rhinosinusitis with nasal polyposis (CRSwNP), asthma, eosinophilic esophagitis, and prurigo nodularis.