Amgen submits US marketing application for once-a-month Repatha

US biotech company Amgen (Nasdaq: AMGN) has submitted a marketing application to the US Food and Drug Administration for a once-a-month dosing of Repatha (evolocumab).

Repatha is currently FDA-approved for bi-weekly administration, as a single-used autoinjector, or once per month using three autoinjectors or prefilled syringes. Repatha was cleared by the FDA last month to lower LDL cholesterol as an adjunct to diet and statin therapy in adults with heterozygous familial hypercholesterolemia, homozygous familial hypercholesterolemia or clinical athersclerotic cardiovascular disease.

Repatha is available as a single-use 140mg prefilled SureClick autoinjector or prefilled syringe that patients can self-administer at the recommended dose for adults of 140mg every two weeks or 420mg once a month. For adults with HoFH, the recommended dose is 420mg once a month.