Tag: Dupixent

October 12, 2022 Off

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 Off

Sanofi’s Dupixent Now Available for Children Aged 6 to 11 Years with Severe Asthma with Type 2 Inflammation

By Author

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 Off

FDA accepts Dupixent (dupilumab) for Priority Review in Patients Aged 12 Years and Older with Eosinophilic Esophagitis

By Author

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 Off

FDA accepts Sanofi’s Dupixent for Priority Review in children aged 6 months to 5 years with moderate-to-severe atopic dermatitis

By Dino Mustafić

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 Off

Dupixent significantly improved disease severity in a trial that met all endpoints

By Dino Mustafić

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 Off

 EC Approves Dupixent as the first biologic medicine for children (6-11) with severe atopic dermatitis 

By Dino Mustafić

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 Off

Dupixent meets primary and key secondary endpoints in eosinophilic esophagitis trial

By Dino Mustafić

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 Off

Sanofi, Regeneron’s Dupixent trial meets both co-primary endpoints

By Dino Mustafić

Dupixent in patients 12 years and older with eosinophilic esophagitis (EoE) trial met both of its co-primary endpoints.

October 29, 2019 Off

European Commission approves Dupixent for severe chronic rhinosinusitis with nasal polyposis

By Dino Mustafić

European Commission has approved a third indication for Dupixent® (dupilumab) for the treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP). Dupixent is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. It is also approved for moderate-to-severe atopic dermatitis and severe asthma.

June 28, 2019 Off

Dupixent gets extended use for certain atopic dermatitis in adolescents

By Dino Mustafić

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has nodded for extension for Dupixent, following USFDA’s approval for nasal polyposis, enabling its approval in the European Union (EU) to also include adolescents 12 to 17 years of age with moderate-to-severe AD who are candidates for systemic therapy.