US FDA approves Dupixent to treat younger kids with esophageal condition

FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

The U.S. health regulator has approved the use of Regeneron and Sanofi’s Dupixent to treat an allergic inflammation of the esophagus in children aged one to 11 years old and weighing at least 15 kg, the companies said on Thursday.

The U.S. Food and Drug Administration (FDA) in 2022 approved the blockbuster anti-inflammatory drug for treating eosinophilic esophagitis (EoE) in patients aged 12 years and older, making it the first for the immune condition in the country.

In EoE, white blood cells called eosinophils build up in the esophagus, resulting in damage and inflammation that can impact the ability to eat food.

About 21,000 children below 12 years are being treated for EoE in the U.S. and around 9,000 of those do not respond satisfactorily to unapproved therapies, Sanofi said in September.

Dupixent’s list price is $3,803.20 per carton for all EoE patients, a Sanofi spokesperson said, adding, most people will not pay the list price.

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 Dupixent made the condition less intense in 66% of patients below the age of 12 in a late-stage study.

The FDA clearance will make Dupixent the first approved drug for younger kids suffering from EoE, Regeneron executive Jennifer Maloney said.

The early intervention may help these younger kids avoid scarring of the esophagus, which can lead to dysphagia, or difficulty in swallowing.

Regeneron and Sanofi are also seeking U.S. approval for use of Dupixent to treat chronic obstructive pulmonary disease (COPD).

COPD, or “smoker’s lung”, affects around 16 million Americans and is the sixth leading cause of death in the country, according to the Centers for Disease Control and Prevention.

The FDA last year declined to approve Dupixent for an inflammatory skin disease called chronic spontaneous urticaria.