FDA approves system that provides once monthly dose of Amgen’s PCSK9 inhibitor

The FDA approved a device from Amgen that provides a monthly, single dose of evolocumab (Repatha) to lower low-density lipoprotein (LDL) cholesterol.

The Pushtronex system delivers 420 mg of evolocumab, a proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor that the FDA approved in August 2015.

Previously, patients received one 140 mg single-use prefilled autoinjection or prefilled syringe of the drug every two weeks. The Pushtronex system will be available in the U.S. in August.

Evolocumab was the second FDA-approved PCSK9 inhibitor, following the July 2015 approval of alirocumab (Praluent). The recommended starting dose for alirocumab is 75 mg administered subcutaneously every two weeks. The medication is also approved in a 150 mg dosage for every two weeks.

Although the PCSK9 inhibitors were expected to be blockbuster medications, sales have so far fallen short of expectations. The Associated Press reported in April that Sanofi reported first quarter sales of $10 million for alirocumab, while Amgen declined to disclose sales of evolocumab.

The annual wholesale acquisition cost is $14,100 for evolocumab and $14,600 for alirocumab. Although out-of-pocket costs vary among patients, the prices of the PCSK9 inhibitors are typically much more expensive than statins, which are the standard of care to lower LDL cholesterol.

The prescribing information for both evolocumab and alirocumab notes that the drugs have not been shown to reduce cardiovascular morbidity and mortality. The companies are currently conducting trials to determine the drugs’ effect on cardiovascular outcomes.