Amgen Gets FDA Approval For PCSK9 Inhibitor

Amgen AMGN revealed that the Food and Drug Administration (FDA) has approved the Repatha (evolocumab) Pushtronex system, a fresh, monthly single-dose administration option. According to the company, the Pushtronex system was a hands-free device meant to offer 420 mg of Repatha in a single dose.

Amgen pointed out that Repatha is a human monoclonal antibody, which blocks a protein known as proprotein convertase subtilisin/kexin type 9 (PCSK9) that inhibits the body's natural system for eliminating "bad" cholesterol from the blood. The company added that Repatha was the first, as well as, the only PCSK9 inhibitor to provide a monthly single-dose delivery option.

The company's EVP R&D, Sean Harper, said, "The Pushtronex system exemplifies Amgen's continued innovation and commitment to patients. 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."

Amgen said the fresh, single-use device was established in alliance with West Pharmaceutical Services, based on the SmartDose technology platform, to offer patients with an additional dosing option for Repatha treatment. The company indicated that the device adhered to the body and that patients were hands free during administration.