Dupixent® has been approved by European Commission arsenic the archetypal and lone targeted medicine indicated for eosinophilic esophagitis.
The European Commission (EC) has expanded the selling authorisation for Dupixent® (dupilumab) successful the European Union (EU) to dainty eosinophilic esophagitis (EoE). It is the “… archetypal and lone targeted attraction enactment clinically proven to trim some oesophageal inflammation and damage,” explained Dr Naimish Patel, Head of Global Development, Immunology and Inflammation at Sanofi.
Dupixent® is indicated for EoE patients 12 years and older, weighing astatine slightest 40kg, who are inadequately controlled by, are intolerant to, oregon who are not candidates for accepted medicinal therapy.
Dupixent arsenic a subcutaneously administered injection is present an enactment for the astir 50,000 patients with uncontrolled EoE successful the EU. The afloat quality monoclonal antibody inhibits the signalling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways. It is disposable arsenic some a pre-filled pen and pre-filled syringe astatine the 300mg dose.
EoE is simply a chronic, progressive inflammatory illness that damages the oesophagus and prevents it from moving properly.
The Phase III proceedings for eosinophilic esophagitis
The three-part Phase III randomised, double-blind, placebo-controlled proceedings evaluated the efficacy and information of Dupixent successful patients aged 12 years and older with EoE. All patients had antecedently not responded to proton pump inhibitors. Across Part A and Part B, of which the support was based on, 74 percent of patients were antecedently treated with swallowed topical corticosteroids.
Approximately 60 percent of patients aged 12 years and older treated with Dupixent 300mg play successful the pivotal proceedings experienced histological illness remission. Patients besides importantly improved their quality to swallow compared to placebo. Improvements were observed arsenic aboriginal arsenic 4 weeks.
Dupixent® delivers histological remission for paediatric EoE patients
“Dupixent is besides the lone biologic shown successful pivotal trials to assistance patients execute histological remission, trim trouble swallowing and amended health-related prime of life,” stated Dr George D Yancopoulos, PhD, President and Chief Scientific Officer astatine Regeneron.
The information results of the proceedings were mostly accordant with the known information illustration of Dupixent successful its approved indications.
Regulatory approvals for Dupixent
Dupixent has received regulatory approvals successful 1 oregon much countries astir the satellite for usage successful definite patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), EoE oregon prurigo nodularis successful antithetic property populations. Dupixent is presently approved for 1 oregon much of these indications successful much than 60 countries, including successful Europe, the US and Japan. More than 500,000 patients person been treated with Dupixent globally.
Dupilumab is being jointly developed by Sanofi and Regeneron nether a planetary collaboration agreement. To date, dupilumab has been studied crossed much than 60 objective trials involving much than 10,000 patients with assorted chronic diseases driven successful portion by benignant 2 inflammation.
English (US)