BETHESDA, MD — In a decision anticipated by many, the US Food and Drug Administration (FDA) approved evolocumab (Repatha, Amgen) for lowering LDL-cholesterol levels. Specifically, the FDA approved evolocumab for use in addition to diet and maximally tolerated statin therapy in adults with heterozygous and homozygous familial hypercholesterolemia (FH) or clinical evidence of atherosclerotic cardiovascular disease who require further LDL-cholesterol lowering.
The approval follows a positive decision from the FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC). The advisory panel reviewed the data in early June and overwhelmingly stated that the benefits of lowering LDL cholesterol with evolocumab outweighed the potential risks.
Evolocumab is the second proprotein convertase subtilisin kexin 9 (PCSK9) inhibitor approved in the US. Last month, the agency approved alirocumab (Praluent, Sanofi/Regeneron) for patients with heterozygous familial hypercholesterolemia or those at high cardiovascular risk who cannot lower their LDL cholesterol with statins.
The FDA recommends evolocumab for use in patients very similar to those in whom alirocumab is currently indicated. Neither drug, despite some speculation there might have been, was approved for use in statin-intolerant patients.
The evolocumab approval is based on data from multiple clinical trials, including studies of patients with heterozygous and homozygous familial hypercholesterolemia, patients unable to tolerate a statin, and patients at high risk for cardiovascular events who are inadequately controlled on statin therapy.
Amgen is currently conducting a large cardiovascular-outcomes study to determine whether lowering LDL cholesterol with evolocumab reduces clinical events. The study, known as FOURIER, will include more than 27,000 patients with clinically evident cardiovascular disease and is expected to be completed in late 2017. The primary end point in the trial is the time to cardiovascular death, MI, hospitalization for unstable angina, stroke, or coronary revascularization.
The dawn of the PCSK9 inhibitor era is not without controversy. The drugs are expensive—alirocumab has been priced at $14,600 per year and evolocumab is expected to be in the same ballpark—and this has led pharmacy benefits managers such Express Scripts to posit the drugs will "wreak financial havoc" on the healthcare system. CVS Health, as reported by heartwire from Medscape, is urging a return to LDL-cholesterol targets to ensure the drugs aren't used inappropriately. CVS hasn't put alirocumab on any of its formularies just yet, waiting until evolocumab was approved before making a coverage decision (and to help with price negotiations from the drugmakers).
Evolocumab is also available in Europe, having been approved by the European Commission in July following a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The European Commission went further than the US FDA in terms of who can use the drug, however, with regulators giving a nod to evolocumab in patients intolerant to statins. Alirocumab is not yet available in Europe, although a decision from the European Commission is expected in September.
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Cite this: FDA Green-lights Evolocumab (Repatha) for LDL-Cholesterol Lowering - Medscape - Aug 25, 2015.