FDA approves alirocumab for treating homozygous familial hypercholesterolemia
The FDA has approved alirocumab as a treatment option for homozygous familial hypercholesterolemia (HoFH), a condition associated with severely high cholesterol.
Alirocumab is a PCSK9 inhibitor manufactured by Regeneron Pharmaceuticals and sold as Praluent. It is administered as a needle injection every two weeks.
Alirocumab has already been approved as a treatment for lowering the risk of heart attack, stroke and unstable angina among certain adult patients with cardiovascular disease.
“Patients with HoFH can develop premature cardiovascular disease, including heart attack and heart disease, when they are teenagers or in their 20s, and many do not improve substantially with other cholesterol-lowering drugs,” according to the FDA. “Without aggressive treatment, patients may die before age 30.”
The FDA’s approval was based on a 12-week randomized trial comparing alirocumab and a placebo in adult HoFH patients. Overall, alirocumab was associated with a 27% decrease in LDL-C; the placebo, meanwhile, was associated with a 9% increase in LDL-C.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.