Amgen said Repatha (evolocumab) reduced the low-density lipoprotein (LDL) cholesterol to desirable target levels in 80 percent of patients with atherosclerotic cardiovascular disease (ASCVD) in a long-term trial.
The U.S. biotech firm disclosed the results of the phase 3 FOURIER open-label extension (OLE) study of Repatha during the late-breaking session of the annual meeting of the European Society of Cardiology (ESC) on Monday in Barcelona, Spain.
Repatha is the first and only proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK9i) to date to show long-term clinical outcomes in patients with ASCVD for up to 8.4 years, Amgen noted.
The FOURIER-OLE study evaluated the long-term safety and tolerability of Repatha in 6,635 adults with ASCVD in the U.S. and Europe who had participated in the previous FOURIER trial for a median follow-up of up to five years. Some patients received Repatha for more than eight years in the parent and extension studies.
The study results showed that Repatha lowered LDL-C levels, with 80 percent of patients achieving the LCL-C level of less than 55mg/dL.
Also, the LDL-C reduction of 58 percent from baseline was consistent over long-term (260 weeks) follow-up on Repatha, the company said.
"The new findings from the FOURIER-OLE studies confirm that earlier initiation of Repatha, combined with longer duration of treatment, has the potential to deliver a greater reduction in cardiovascular risk, including death," said David M. Reese, executive vice president of Research and Development at Amgen. "These data add to the robust body of evidence for Repatha, demonstrating that long-term treatment with Repatha is well tolerated in patients with stable ASCVD."
Earlier in June, Amgen Korea and Jeil Pharmaceutical signed an agreement to sell Repatha together. The two companies handle sales and marketing of Repatha for tertiary and general hospitals, and Jeil, at smaller hospitals and clinics alone.
Amgen obtained the permit for Repatha in April 2017 and added indications such as atherosclerotic cardiovascular disease, primary hypercholesterolemia, and mixed dyslipidemia in August 2018.