FDA Approves Repatha for Prevention of Cardiovascular Events

FDA approved Evolocumab (Repatha, Amgen) to prevent heart attacks, strokes, and coronary revascularizations in adults with established cardiovascular disease have turned into the first PCSK9 inhibitor. The FDA likewise approved evolocumab to be utilized as an adjunct to diet, alone or in combination with other lipid-lowering treatments, for example, statins, for the treatment of adults with primary hyperlipidemia to reduce low- density lipoprotein-cholesterol (LDL-C).

Sean E. Harper, MD, official VP of Research and Development at Amgen said, “In spite of treatment with current best treatment, numerous patients are still at high risk for cardiovascular events. Doctors now have a new FDA- approved treatment option to prevent heart attacks, strokes, and coronary revascularizations by drastically lowering LDL cholesterol with Repatha, particularly for patients already on maximally- tolerated statin treatment who require further LDL cholesterol lowering.”

The Repatha cardiovascular results study (FOURIER) showed that adding evolocumab to upgraded statin treatment resulted in a statistically significant 20% (P < 0.001) reduction in major adverse cardiovascular events (MACE) represented in the key secondary composite endpoint of first time heart attack, stroke, or cardiovascular death. The examination found a statistically significant 15% reduction (P < 0.001) in the risk of the essential composite endpoint, which included hospitalization for unstable angina, coronary revascularization, heart assault, stroke, or cardiovascular death.

The extent of risk decrease in both the essential and key secondary composite endpoints developed after some time, with the robust advantage beginning as ahead of schedule as a half year and accruing through the middle 2.2 years of the examination. Patients on evolocumab encountered a reduction in the risk of heart assault (27%, ostensible P < 0.001), stroke (21%, ostensible P = 0.01) and coronary revascularization (22%, ostensible P < 0.001). Steady with recent trials of more concentrated LDL-C lowering, there was no observed impact on cardiovascular mortality. Additionally, there was no observed impact on hospitalization for unstable angina.

The safety profile of evolocumab in the results trial was generally steady with the safety profile for the 12-and 52-week controlled trials involving patients with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH). Most common adverse reactions include diabetes mellitus, nasopharyngitis, and upper respiratory tract infection. The FDA gave priority review to Amgen’s supplemental biologics license application for the new indication.


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