US FDA approves Dupixent to treat younger kids with esophageal condition

US FDA approves Dupixent to treat younger kids with esophageal condition

Jan 25 (Reuters) – 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.