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Re: DewDiligence post# 193706

Thursday, 08/27/2015 5:17:41 PM

Thursday, August 27, 2015 5:17:41 PM

Post# of 257443
FDA approves AMGN’s Repatha—label apparently similar to Praluent’s in excluding primary prevention in general population (but it differs from Praluent's label by including HoPH):

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm460082.htm

The U.S. Food and Drug Administration today approved Repatha (evolocumab) injection for some patients who are unable to get their low-density lipoprotein (LDL) cholesterol under control with current treatment options.

Repatha, the second drug approved in a new class of drugs known as PCSK9 inhibitors, is approved for use in addition to diet and maximally-tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia (HeFH), homozygous familial hypercholesterolemia (HoFH), or clinical atherosclerotic cardiovascular disease, such as heart attacks or strokes, who require additional lowering of LDL cholesterol [i.e. secondary prevention].

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