Dupixent® Receives FDA Approval to Treat EoE in People Ages 12 and Older

Dupixent® Receives FDA Approval to Treat EoE in People Ages 12 and Older

Injection is the first indicated treatment for EoE

 

May 21, 2022:  APFED (The American Partnership for Eosinophilic Disorders) is pleased to share the exciting news that the first treatment for eosinophilic esophagitis (EoE) has been approved by the U.S. Food and Drug Administration (FDA) during National Eosinophil Awareness Week.

The FDA approved Dupixent® (dupilumab), jointly developed by pharmaceutical companies Sanofi and Regeneron, for treatment of adults and children 12 years and older with EoE. This chronic inflammatory condition is characterized by the presence of white blood cells called eosinophils in the esophagus.  Eosinophils cause inflammation in the esophagus and damage to the tissue, leading to symptoms of difficulty swallowing, food getting stuck in the esophagus, pain, vomiting, and malnutrition.  Treatments to date have included eliminating allergy-causing food from the diet, proton pump inhibitors, and off-label use of swallowed steroids.

APFED congratulates Sanofi and Regeneron for their commitment to developing Dupixent® and for funding the LIBERTY EoE TREET clinical studies, which demonstrated significant decrease of the number of eosinophils in the esophagus as well as improved symptoms in patients with EoE treated with Dupixent® compared to placebo. APFED would also like to thank the FDA for its priority review for this breakthrough treatment that has the potential to improve the lives of people living with EoE, and to all those who selflessly participated in research and clinical trials so that developments such as dupilumab could advance.

“The fact that this news comes during National Eosinophil Awareness Week is incredible,” said APFED’s Executive Director Mary Jo Strobel. “Fifteen years ago, APFED set out to establish an official awareness week, which was formally recognized by the U.S. House of Representatives through House Bill 296. The purpose of the week is to create awareness and educate the general public and the medical community about eosinophil-associated diseases. With greater awareness, a supportive community develops, and the need for research and improved therapies is amplified. The FDA’s decision to grant approval to Dupixent® to treat EoE is very welcome news to our community.”

“APFED was founded in 2001 with the mission to support patients and families affected by EoE and other eosinophil-associated disorders by educating patients, providers, and the public about these conditions, advocating for patients’ needs, and supporting research,” said APFED’s President Dr. Wendy Book. “Since 2006, thanks to community donations, APFED has awarded nearly $2 million in grants to investigators to advance research in eosinophilic disorders through a rigorous application process.” Many of the research projects APFED funded involved research of the immune and inflammatory pathways involved in the development of EoE. Having the pathways to inflammation identified helps guide potential future therapies.

Dr. Prad Tummala, Chairman of APFED’s Board of Directors, adds, “APFED hopes that the current success of Dupixent® is the first of many therapies that will be discovered as a result of ongoing research in the field of eosinophilic disorders. APFED depends on the generosity of donors to continue to support research and hopes that this exciting announcement of the first FDA-approved therapy indicated for EoE treatment will inspire more members of the community to donate to research, as it demonstrates the value of investing in it.”

Ryan Piansky, a young adult who was diagnosed with EoE in early childhood, shares the excitement patients and families feel about the FDA approval. “APFED has always provided hope to patients and families living with eosinophilic diseases. As a patient with EoE who met with members of Congress to help pass the National Eosinophil Awareness Week resolution, I am thrilled to hear of the first FDA approved treatment indicated for EoE. APFED’s commitment to finding treatments for these rare diseases provides a beacon of hope.”

To learn more about APFED’s HOPE on the Horizon Research Program and to make a donation, please visit apfed.org.

Read More

• FDA Press Release: FDA approves first treatment for eosinophilic esophagitis, a chronic immune disorder
• Sanofi Press Release: FDA approves Dupixent® (dupilumab) as first treatment for adults and children aged 12 and older with eosinophilic esophagitis