Monthly PCSK9 Inhibitor Drug-Device Approved

The US Food and Drug Administration approved a new way to administer evolucumab (Repatha/Amgen) monthly with a preloaded device called the Repatha/Pushtronex System. The manufacturer describes the device as a hands-free "on-body infusor with prefilled cartridge." The drug is delivered subcutaneously.

The drug is already available as a twice-monthly injection.

In the US evolucumab is approved for heterozygous familial hypercholesterolemia and clinical atherosclerotic cardiovascular disease and for patients who cannot get their LDL cholesterol low enough with statins alone.

The effect of the drug on cardiovascular morbidity has not been determined, though two ongoing studies are looking at whether patients would benefit if they get the drug after cardiac catheterization and, in a separate study, whether it could be used with statins to reduce cardiovascular risk in patients with high cholesterol and cardiovascular disease.

It is approved in 43 countries, but has been controversial in the US because of its high cost ($14,000 a year wholesale) compared to statins.

Evolucumab is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). The drug binds to PCSK9 and inhibits circulating PCSK9 from binding to the low-density lipoprotein receptor, making these receptors available to clear the blood of harmful cholesterol.