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Dupixent® (dupilumab) FDA Approved as First and Only Treatment Indicated for Children Aged 1 Year and Older with Eosinophilic Esophagitis (EoE)

Retrieved on: 
Thursday, January 25, 2024
Ageing, Regeneron Pharmaceuticals, Patient, Histology, Failure, Diagnosis, Medicine, Heartburn, Risk, Lower respiratory tract infection, Food, Arthralgia, Chronic pain, Safety, Disease, Esophagus, Inflammation, Helminthiasis, Priority review, FDA, Eosinophilic esophagitis, Prevalence, Vomiting, International development, Growth, Pharmaceutical industry

TARRYTOWN, N.Y. and PARIS, Jan. 25, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for the treatment of pediatric patients aged 1 to 11 years, weighing at least 15 kg, with eosinophilic esophagitis (EoE). Dupixent is now the first and only medicine approved in the U.S. specifically indicated to treat these patients. This approval expands the initial FDA approval for EoE in May 2022 for patients aged 12 years and older, weighing at least 40 kg. The FDA evaluated Dupixent for this expanded indication under Priority Review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in treating serious conditions.

Key Points: 
  • Dupixent is now the first and only medicine approved in the U.S. specifically indicated to treat these patients.
  • This approval expands the initial FDA approval for EoE in May 2022 for patients aged 12 years and older, weighing at least 40 kg.
  • Approximately 21,000 children under the age of 12 in the U.S. are currently being treated for EoE with unapproved therapies.
  • “With this approval, Dupixent becomes the first and only treatment option for EoE patients aged 1 and older, weighing at least 15 kg.

Dupixent® (dupilumab) Approved by European Commission as the First and Only Targeted Medicine Indicated for Eosinophilic Esophagitis

Retrieved on: 
Monday, January 30, 2023
Royal commission, Inflammation, Immunology, Bruise, Eosinophilic esophagitis, Safety, Conjunctivitis, European Commission, Eosinophilia, Ageing, EC, Esophagus, Medicare Part D, Patient, Union, Arthralgia, Regeneron Pharmaceuticals, DSQ, Choking, Infection, Pain, International development, Pharmaceutical industry, Medical imaging, EU, Sanofi, EOE, Dupilumab, Part

TARRYTOWN, N.Y. and PARIS, Jan. 30, 2023 (GLOBE NEWSWIRE) --  Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Commission (EC) expanded the marketing authorization for Dupixent® (dupilumab) in the European Union (EU) to treat eosinophilic esophagitis (EoE) in adults and adolescents 12 years and older, weighing at least 40 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy. EoE is a chronic, progressive inflammatory disease that damages the esophagus and prevents it from working properly. With this approval, Dupixent is the first and only targeted medicine specifically indicated to treat EoE in Europe and the U.S.

Key Points: 
  • EoE is a chronic, progressive inflammatory disease that damages the esophagus and prevents it from working properly.
  • With this approval, Dupixent is the first and only targeted medicine specifically indicated to treat EoE in Europe and the U.S.
    “This latest approval establishes Dupixent as the only targeted medicine specifically indicated for eosinophilic esophagitis in the European Union.
  • “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.
  • The safety results of the trial were generally consistent with the known safety profile of Dupixent in its approved indications.