March 1, 2024
Dupixent shows promise in treating severe asthma
New findings from the VESTIGE trial reveal the effectiveness of Dupixent (dupilumab) in managing uncontrolled moderate-to-severe asthma.
Pharmaceuticals, Biotechnology and Life Sciences
Tag: Dupixent
September 29, 2023
FDA puts Dupixent in priority review for treatment of eosinophilic esophagitis in children younger than 12
Regeneron Pharmaceuticals and Sanofi have received U.S. Food and Drug Administration (FDA) acceptance for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) to treat children aged 1 to 11 years with eosinophilic esophagitis (EoE).
October 12, 2022
Sanofi, Regeneron: first and only Phase 3 trial in children with EoE shows positive results
Dupixent presented detailed data at this year’s UEG Week conference in Vienna from from an investigational Phase 3 trial showing positive results in children ages 1 to 11 years old who are living with eosinophilic esophagitis (EoE). EoE is a chronic, progressive inflammatory disease that damages the esophagus and prevents it from working properly. Of the approximately 21,000 children under the age of 12 in the U.S. currently being treated for EoE, approximately 9,000 are most in need of new treatment options.
April 7, 2022
Sanofi’s Dupixent Now Available for Children Aged 6 to 11 Years with Severe Asthma with Type 2 Inflammation
The European Commission (EC) has expanded the marketing authorization for Sanofi’s Dupixent (dupilumab) in the European Union to include treatment of children aged 6 to 11 years as an add-on maintenance treatment for uncontrolled severe asthma.
April 4, 2022
FDA accepts Dupixent (dupilumab) for Priority Review in Patients Aged 12 Years and Older with Eosinophilic Esophagitis
The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Sanofi’s…
February 10, 2022
FDA accepts Sanofi’s Dupixent for Priority Review in children aged 6 months to 5 years with moderate-to-severe atopic dermatitis
The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Sanofi’s…
December 13, 2021
Dupixent significantly improved disease severity in a trial that met all endpoints
Positive Phase 3 results show adding Dupixent (dupilumab) to standard-of-care topical corticosteroids (TCS) significantly improved skin clearance and reduced overall disease severity and itch in infants and children aged 6 months to 5 years with uncontrolled moderate-to-severe atopic dermatitis.
November 30, 2020
EC Approves Dupixent as the first biologic medicine for children (6-11) with severe atopic dermatitis
Regeneron Pharmaceuticals and Sanofi today announced that the European Commission (EC) has extended the marketing authorization for Dupixent (dupilumab) in the European Union (EU) to include children 6 to 11 years of age with severe atopic dermatitis who are candidates for systemic therapy. Dupixent is the only systemic medicine approved in the EU to treat these patients.
June 1, 2020
Dupixent meets primary and key secondary endpoints in eosinophilic esophagitis trial
Regeneron Pharmaceuticals and Sanofi have shared positive results from Part A of the pivotal Phase 3 trial evaluating Dupixent in patients 12 years and older with eosinophilic esophagitis (EoE), in which the trial met both co-primary endpoints.
May 23, 2020
Sanofi, Regeneron’s Dupixent trial meets both co-primary endpoints
Dupixent in patients 12 years and older with eosinophilic esophagitis (EoE) trial met both of its co-primary endpoints.