((Automated translation by Reuters, please see disclaimer https://bit.ly/rtrsauto))
(Added executive commentary to paragraph 7 and general information throughout) by Leroy Leo and Puyaan Singh
The US health regulator has approved the use of Regeneron REGN.O and Sanofi SASY.PA’s Dupixent to treat allergic inflammation of the esophagus in children aged 1 to 11 years and weighing at least 15 kg, announced businesses Thursday.
In 2022, the U.S. Food and Drug Administration (FDA) approved this blockbuster anti-inflammatory for the treatment of eosinophilic esophagitis (EOS) in patients aged 12 and older, making it the first drug for this immune condition in the country.
In esophagitis, white blood cells called eosinophils build up in the esophagus, causing damage and inflammation that can impact the ability to eat.
About 21,000 children under the age of 12 are treated for EoE in the United States and about 9,000 of them do not respond satisfactorily to unapproved treatments, Sanofi said in September.
Dupixent, currently used to treat eczema, asthma and other inflammatory conditions, generated global sales of $8.68 billion in 2022.
The latest approval comes after a higher dose of Dupixent reduced disease intensity in 66% of patients younger than 12 years in a late-phase study.
The regulator’s green light will make Dupixent the first drug approved for young children with the condition, said Jennifer Maloney, an executive at Regeneron.
Early intervention can help these young children avoid scarring of the esophagus, which can lead to dysphagia, or difficulty swallowing.
Regeneron and Sanofi are also seeking US marketing authorization for Dupixent for the treatment of chronic obstructive pulmonary disease (COPD).
COPD, also known as “smoker’s lung,” affects approximately 16 million Americans and is the sixth leading cause of death in the country, according to the Centers for Disease Control and Prevention (CDC).
Last year, the FDA refused to approve Dupixent for an inflammatory skin disease called chronic spontaneous urticaria.