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Evolocumab recommended for approval in Europe

May 22, 2015

Amgen announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion for the marketing authorization of the PCSK9 inhibitor evolocumab, recommending approval for use in certain patients with high cholesterol, according to a press release.

The committee recommended granting evolocumab (Repatha, Amgen) marketing authorization for the treatment of patients with primary hypercholesterolemia as an adjunct to diet. Evolocumab was recommended for administration in combination with a statin, with or without additional lipid-lowering therapies, among patients who were unable to achieve their target LDL with the maximum tolerated statin dose. Among statin-intolerant patients or those in whom statins are contraindicated, the committee recommended authorization for evolocumab alone or in combination with other lipid-lowering therapies, according to the release.

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CME
Best of Lipid Forum III

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This activity is supported by an educational grant from Amgen, Inc.

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CME
Severe Hypertriglyceridemia: Confronting the Complex Issues in Etiology and Treatment

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This activity is supported by an educational grant from AstraZeneca.

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Evolocumab recommended for approval in Europe

May 22, 2015
Amgen announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion for the…
Meeting News Coverage

High-intensity statin use low in patients with diabetes, high CVD risk

May 22, 2015
NASHVILLE, Tenn. - Patients with type 2 diabetes at very high risk for cardiovascular disease are often not taking high-intensity statins, further…
Sanghamitra Mohanty, MD, FHRS Meeting News Coverage

Effect of exercise on AF risk differs by sex

May 21, 2015
BOSTON — Among those with atrial fibrillation, women who engage in moderate and vigorous physical activity and men who engage in moderate…
Meeting News CoveragePerspective

Metformin plays role in reducing MI, heart failure risk

May 21, 2015
NASHVILLE, Tenn. — Even slight weight effects associated with metformin use may reduce risk for myocardial infarction and heart failure…
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