(Reuters) – Regeneron Pharmaceuticals Inc said on Wednesday the U.S. Food and Drug Administration had approved the expanded use of its drug in children aged 5 to 11 to treat an ultra-rare disease that causes high cholesterol levels.
The drug, Evkeeza, is already approved as an additional treatment, along with other lipid-lowering therapies, for patients aged 12 years and older with homozygous familial hypercholesterolemia (HoFH).
HoFH is an inherited condition that affects about 1,300 people in the United States.
The expanded approval makes the drug the first to treat kids with the condition who are less than 10 years old.
The list price of the drug varies by patient weight, and is expected to be roughly $450,000 per year on average, Regeneron had said in 2021.
(Reporting by Khushi Mandowara and Sriparna Roy in Bengaluru; Editing by Shinjini Ganguli)
