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September 28, 2021September 24, 2021 – The U.S. FDA has approved expanded indications for Repatha® (evolocumab). The drug is now indicated as an add-on treatment for patients who are at least 10 years old and have heterozygous familial hypercholesterolemia (HeFH) or homozygous familial hypercholesterolemia (HoFH).
- Previously, Repatha was approved to treat HeFH in adults only, and HoFH in patients who were at least 13 years old. Both conditions are rare genetic diseases that cause dangerously high levels of LDL cholesterol, commonly referred to as bad cholesterol.
- Under the expanded indications, Repatha should be used alongside diet and/or other cholesterol-
lowering therapies. Recommended dosing is based on the indication:
- HeFH: 140mg every two weeks or 420mg once monthly.
- HoFH: 420mg once monthly to start, with the possibility of increasing to 420mg every two weeks if a clinically meaningful response is not achieved in 12 weeks.
- Repatha is a subcutaneous injection manufactured by Amgen and first FDA approved in 2015.