Amgen Seeks FDA OK for One-Monthly Dosing for New Cholesterol Drug
Amgen has submitted an application to the US Food and Drug Administration (FDA) seeking approval of a single-dosing option for the monthly administration of Repatha (evolocumab) Injection, allowing the 420 mg monthly dose to be administered as a single injection. Approved by the FDA on Aug. 27, 2015, Repatha is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). PCSK9 is a protein that reduces the liver’s ability to remove low-density lipoprotein cholesterol (LDL-C), or “bad” cholesterol, from the blood.
Repatha is approved as an adjunct to diet and maximally tolerated statins in patients with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of LDL-C; and as an adjunct to diet and other LDL-lowering therapies for the treatment of patients with homozygous familial hypercholesterolemia (HoFH), who require additional lowering of LDL-C. .
Repatha is available as a single-use 140 mg/mL prefilled SureClick autoinjector or prefilled syringe that patients can self-administer at the recommended dose for adults of 140 mg every two weeks or 420 mg once a month. For patients with HoFH, the recommended dose is 420 mg once a month.
Repatha, along with Sanofi’s/Regeneron’s Praluent (alirocumab), also a PCSK9 inhibitors, are pegged as potential blockbusters. Based on estimates for 2019 sales, a recent Thomson Reuters analysis puts potential revenues at Regeneron Pharmaceuticals and Sanofi's Praluent (alirocumab) at $4.4 billion, and Amgen's’ evolocumab at nearly $1.9 billion by 2019. Praluent received FDA approval in July, and the drug is under regulatory review in the European Union (EU) for which a decision is expected for late September. Repatha is approved in both the EU and the US.