Amgen's Repatha becomes world's first approved PCSK9 inhibitor
- Amgen's Repatha (evolocumab) has been approved in the E.U. for treatment of uncontrolled hypercholesterolemia when other treatment regimens are not sufficient.
- In the E.U., 60% of high-risk patients with hypercholesterolemia are still unable to control their LDL-C with their current regimens.
- Repatha is a human monoclonal antibody that inhibits the PCSK9 protein—a protein that reduces the body's ability to remove LDL-C from the blood.
The big question was which PSCK9 inhibitor will make it to market first, and the contest was between Amgen's Repatha and Sanofi's Praluent (alirocumab). Approval is based on strong clinical trial data showing a treatment-related reduction in LDL-C of 55% to 75% versus placebo, as well as a 35% to 45% decrease in LDL-C, compared with Merck's exetimbe. And when it comes to very hard-to-treat familial hypercholesterolemia, Repatha was able to decrease LDL-C levels by 15% to 30%.
The world has been waiting, and finally the era of the PCSK9 inhibitor has arrived—and although Repatha was first to market, Praluent will likely not be far behind, and may even win approval in the U.S. as early as this Friday (giving it an advantage over Repatha in the American market).
Want the complete A-to-Z lowdown on PCSK9 inhibitors? Check out Biopharma Dive's "9 important things to know about PCSK9 cholesterol drugs."
- Pharma Times World first: Amgen's PCSK9 inhibitor approved in EU