FDA Approves First Treatment for 1-Year-Olds with Ultra-Rare Cholesterol Disorder - Regeneron's Breakthrough

FDA Expands Evinacumab-dgnb Approval for Children as Young as 1 Year With HoFH

Evinacumab-dgnb approval expands treatment options for children with homozygous familial hypercholesterolemia (HoFH).

FDA Approves Extended Indication for Evkeeza

Evkeeza is now approved for the treatment of homozygous familial hypercholesterolemia (HoFH) in patients as young as 1 year old.

FDA approves evinacumab-dgnb in children as young as 1 year with HoFH

The approval expands on the previous indication of children 5 years and older with HoFH, approved in 2023.

FDA Approves First Treatment for 1-Year-Olds with Ultra-Rare Cholesterol Disorder - Regeneron's Breakthrough

Evkeeza, showing 50% LDL-C reduction, now approved for children 1-5 years with homozygous hypercholesterolemia (HoFH). Treatment addresses 1,300 US patients with dangerous 400mg/dL cholesterol levels.