FDA Approves Single-Monthly PCSK9 Inhibitor Injection

The FDA on Monday approved the first and only single monthly injection for a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, called the evolocumab (Repatha) Pushtronex system.

Repatha is a human monoclonal antibody that inhibits the PCSK9 protein by binding to it and preventing circulating PCSK9s from binding to the low-density lipoprotein (LDL) receptor (LDLR). This stops PCSK9-mediated LDLR degradation and allows LDLR to recycle back to the surface of the liver cell.

The Pushtronex system is a hands-free device designed to provide a single dose of 420-mg of Repatha. Through collaboration with West Pharmaceutical Services, based on the SmartDose technology platform, the single-dose device was developed.

The device is hands-free during administration and adheres to the patient’s body, allowing them to perform moderate physical activities while the dose of Repatha is being delivered.

“The Pushtronex system exemplifies Amgen’s continued innovation and commitment to patients,” said Sean E. Harper, MD, executive vice president of Research and Development at Amgen. “Repatha is the only PCSK9 inhibitor with an approved monthly dose, and now the only one with a monthly single-dose administration. The FDA approval of the Pushtronex system offers another delivery option to patients who need the additional LDL cholesterol lowering that Repatha can provide.”

The system will be available to patients in the United States in early August. Currently, the US Wholesale Acquisition Cost (WAC) price of Repatha is $14,100 annually. However, the actual costs for patients, payers, and health systems are expected to be lower than that since the WAC pricing does not take into account rebates or discounts, according to an Amgen press release.

For out-of-pocket costs, they will vary for patients depending on their insurance status and eligibility for patient assistance.