Dupilumab

Dupixent® (dupilumab) Late-Breaking Data at AAD Show Significant Improvements in Signs and Symptoms of Moderate-to-severe Atopic Hand and Foot Dermatitis

Retrieved on: 
Saturday, March 18, 2023

TARRYTOWN, N.Y. and PARIS, March 18, 2023 (GLOBE NEWSWIRE) --  Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today presented positive results from the clinical trial assessing Dupixent® (dupilumab) in adults and adolescents with uncontrolled moderate-to-severe atopic hand and foot dermatitis. The trial, the first evaluating a biologic for this difficult-to-treat population, met its primary and key secondary endpoints. The results were featured in a late-breaking session, one of more than 20 Dupixent scientific presentations, at the American Academy of Dermatology (AAD) 2023 Annual Meeting.

Key Points: 
  • The trial, the first evaluating a biologic for this difficult-to-treat population, met its primary and key secondary endpoints.
  • The results were featured in a late-breaking session, one of more than 20 Dupixent scientific presentations, at the American Academy of Dermatology (AAD) 2023 Annual Meeting.
  • There were significant improvements in measures of hand and foot skin pain, sleep, and hand eczema-related quality of life.
  • The trial demonstrated similar safety results to the known safety profile of Dupixent in atopic dermatitis.

Press Release: Dupixent® (dupilumab) late-breaking data at AAD show significant improvements in signs and symptoms of moderate-to-severe atopic hand and foot dermatitis

Retrieved on: 
Saturday, March 18, 2023

Positive results from the clinical trial assessing Dupixent® (dupilumab) in adults and adolescents with uncontrolled moderate-to-severe atopic hand and foot dermatitis were presented today.

Key Points: 
  • Positive results from the clinical trial assessing Dupixent® (dupilumab) in adults and adolescents with uncontrolled moderate-to-severe atopic hand and foot dermatitis were presented today.
  • The trial, the first evaluating a biologic for this difficult-to-treat population, met its primary and key secondary endpoints.
  • “Atopic hand and foot dermatitis can extensively disrupt the lives of patients, given the intense itch and painful skin lesions it causes on essential body areas.
  • There were significant improvements in measures of hand and foot skin pain, sleep and hand eczema-related quality of life.

MARKETVUE® REPORT: Over 80% of U.S. gastroenterologists have prescribed Dupixent for Eosinophilic Esophagitis since its 2022 approval

Retrieved on: 
Tuesday, February 21, 2023

NEWTON, Mass., Feb. 21, 2023 /PRNewswire/ -- Despite being recognized as a distinct etiology of eosinophilic gastrointestinal disease for less than 30 years, EoE care has evolved to include four treatment options:

Key Points: 
  • First-to-market Regeneron/Sanofi's Dupixent (dupilumab) sees strong uptake in Eosinophilic Esophagitis (EoE) since its May 2022 FDA approval, according to findings from REACH Market Research .
  • Physicians are eager for more diverse EoE treatment options including FDA-approved corticosteroids and new therapies that can improve histologic and symptomatic response.
  • Melissa Curran, Director at REACH: "With few prognostic markers to guide treatment recommendations, treatment selection is primarily patient driven.
  • Physicians usually present all classes of treatments to patients and educate on the pros and cons of each option.

Drug Inflation Rate Continues Upward Trend at 3.78%: Vizient Pharmacy Market Outlook

Retrieved on: 
Thursday, January 26, 2023

Vizient, Inc. released its Winter 2023 Pharmacy Market Outlook, forecasting a 3.78% overall drug price inflation rate for the calendar year beginning, July 1, 2023.

Key Points: 
  • Vizient, Inc. released its Winter 2023 Pharmacy Market Outlook, forecasting a 3.78% overall drug price inflation rate for the calendar year beginning, July 1, 2023.
  • The rate reflects a moderate rise relative to recent years but also a growing upward trend led by an increase in prices and utilization.
  • Drug spend for remdesivir (Veklury®), which soared to the top of total Vizient member spend in the Winter 2022 Outlook, continues its decline from No.
  • Vizient continues to advocate for greater transparency throughout the pharmaceutical supply chain to bolster supply assurance and end drug shortages.

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

Retrieved on: 
Monday, January 30, 2023

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.

Press Release:  Dupixent® (dupilumab) approved by European Commission as the first and only targeted medicine indicated for eosinophilic esophagitis

Retrieved on: 
Monday, January 30, 2023

EoE is a chronic, progressive inflammatory disease that damages the esophagus and prevents it from working properly.

Key Points: 
  • EoE is a chronic, progressive inflammatory disease that damages the esophagus and prevents it from working properly.
  • 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.
  • The safety profile through 52 weeks was generally consistent with the safety profile observed at 24 weeks.

Dupixent® (dupilumab) Recommended for Expanded EU Approval by the CHMP to Treat Children as Young as Six Months Old with Severe Atopic Dermatitis

Retrieved on: 
Friday, January 27, 2023

TARRYTOWN, N.Y. and PARIS, Jan. 27, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Dupixent® (dupilumab), recommending expanded approval in the European Union (EU) to treat severe atopic dermatitis in children 6 months to 5 years old who are candidates for systemic therapy. The European Commission is expected to announce a final decision on the Dupixent application in the coming months. In June 2022, Dupixent was approved by the U.S. Food and Drug Administration for children in this age group.

Key Points: 
  • The European Commission is expected to announce a final decision on the Dupixent application in the coming months.
  • In June 2022, Dupixent was approved by the U.S. Food and Drug Administration for children in this age group.
  • Severe atopic dermatitis may also significantly impact the quality of life of young children and their caregivers.
  • The use of Dupixent in infants and young children less than 6 years of age with severe atopic dermatitis is investigational in the EU and is not yet approved.

Press Release: Dupixent® (dupilumab) recommended for expanded EU approval by the CHMP to treat children as young as six months old with severe atopic dermatitis

Retrieved on: 
Friday, January 27, 2023

The European Commission is expected to announce a final decision on the Dupixent application in the coming months.

Key Points: 
  • The European Commission is expected to announce a final decision on the Dupixent application in the coming months.
  • In June 2022, Dupixent was approved by the U.S. Food and Drug Administration for children in this age group.
  • Severe atopic dermatitis may also significantly impact the quality of life of young children and their caregivers.
  • The use of Dupixent in infants and young children less than 6 years of age with severe atopic dermatitis is investigational in the EU and is not yet approved.

Press Release: Positive Dupixent® (dupilumab) Phase 3 results in adults and adolescents with eosinophilic esophagitis published in the New England Journal of Medicine

Retrieved on: 
Wednesday, December 21, 2022

EoE is a chronic, progressive inflammatory disease that damages the esophagus and prevents it from working properly.

Key Points: 
  • EoE is a chronic, progressive inflammatory disease that damages the esophagus and prevents it from working properly.
  • These Phase 3 data have been submitted to the European Medicines Agency (EMA) to support regulatory approval for adults and adolescents with EoE.
  • The EMA’s Committee for Medicinal Products for Human Use recently adopted a positive opinion recommending approval with a final decision expected in the coming months.
  • “The publication of these Phase 3 results in the New England Journal of Medicine reinforces the impact of the clinical trial data.

UNC Health Provider Ushers in First FDA-Approved Medication for Eosinophilic Esophagitis

Retrieved on: 
Thursday, December 22, 2022

Eosinophilic esophagitis (EoE) is an allergic condition of the esophagus that is on the rise throughout the United States.

Key Points: 
  • Eosinophilic esophagitis (EoE) is an allergic condition of the esophagus that is on the rise throughout the United States.
  • View the full release here: https://www.businesswire.com/news/home/20221222005534/en/
    Evan Dellon, MD, MPH, professor of medicine at the UNC School of Medicine and director of the Center for Esophageal Diseases and Swallowing.
  • There is one approved treatment for EoE in several other countries, but it is not available for use in the United States.
  • Dellon believes that initially most doctors will prescribe the therapy for their more severe patients who weren’t responding to prior therapies.