FDA Drug Approvals, Cardiology — 2021 Midyear Review

August 20, 2021

Evkeeza (evinacumab)

Evinacumab is a recombinant human monoclonal antibody that binds to and inhibits angiopoietin–like 3 (ANGPTL3). ANGPTL3 inhibits lipoprotein lipase and endothelial lipase, thereby reducing lipid metabolism. Evinacumab inhibits ANGPTL3 and results in increased lipid metabolism, leading to decreased low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol, and triglycerides. Evinacumab is indicated as an adjunct to other LDL-C–lowering therapies for homozygous familial hypercholesterolemia in adults and adolescents aged 12 years and older.

Approval was based on the phase 3 ELIPSE trial (n = 65). The study found that patients undergoing stable lipid-lowering treatment in whom an intravenous infusion of evinacumab was administered every 4 weeks achieved, by week 24, a 47.1% relative reduction in their LDL-C level compared with a 1.9% increase seen in patients treated with a placebo (P <.001). N Engl J Med . 2020;383:711-720

Verquvo (vericiguat)

Vericiguat stimulates soluble guanylate-cyclase (sGC), the intracellular receptor for endogenous nitric oxide (NO), which catalyzes cyclic guanosine monophosphate (cGMP) production; cGMP plays a role in the regulation of vascular tone, cardiac contractility, and cardiac remodeling. By directly stimulating sGC, independently of and synergistically with NO, vericiguat augments levels of intracellular cGMP, leading to smooth muscle relaxation and vasodilation. Vericiguat is indicated to reduce risk of cardiovascular death and heart failure (HF) hospitalization, following a hospitalization for HF or need for outpatient intravenous diuretics, in adults with symptomatic chronic HF and ejection fraction less than 45%.

Results from the phase 3 VICTORIA trial (n = 5050) study showed that in patients with symptomatic chronic HF (New York Heart Association class II-IV) and left ventricular ejection fraction of less than 45%, vericiguat was superior to placebo in reducing the risk of cardiovascular death or heart failure hospitalization. These results were based on a time-to-event analysis (hazard ratio, 0.9; 95% confidence interval, 0.82-0.98; P = .02) and demonstrated an adverse event profile similar to placebo. N Engl J Med . 2020; 382:1883-1893

Other cardiology approvals

Praluent (alirocumab) - Indicated as an adjunct to other low-density lipoprotein cholesterol (LDL-C)–lowering therapies in adults with homozygous familial hypercholesterolemia to reduce LDL-C.

Entresto (sacubitril/valsartan) - Indication for heart failure expanded to include adults with preserved left ventricular ejection fraction.

Arcalyst (rilonacept) - Interleukin-1 inhibitor for treatment of recurrent pericarditis and to reduce risk of future recurrence in adults and children aged 12 years and older.

Roszet (rosuvastatin/ezetimibe) - New combination indicated to reduce low-density lipoprotein cholesterol in patients with primary nonfamilial hyperlipidemia or homozygous familial hypercholesterolemia.


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