Amgen's Repatha under fire over cardiovascular outcomes data in key trial
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Amgen's PCSK9 inhibitor for lowering cholesterol, Repatha (evolocumab), may lead to cardiac harm, according to a reassessment of data from a late-stage trial of the biologic.
The trial, FOURIER, helped lay the foundation for claims from Amgen (NASDAQ:AMGN) that Repatha in combination with a statin reduces the risk of cardiovascular events.

Writing in the journal BMJ Open, researchers said that there are "some inconsistencies" between information in the Clinical Study Report ("CSR") and what was found in the 2017 primary trial results publication.
"When comparing the CSR information with the 2017 primary results publication, we found 11 more deaths from myocardial infarction in the evolocumab group (36 vs 25) and 3 less deaths in the placebo group (27 vs 30, respectively)," the researchers wrote.
They added that in the CSR, the number of deaths due to cardiac failure in the evolocumab group was 31 compared to 16 in the placebo group.
The researchers conclude that a "complete restoration" of the FOURIER data is needed and doctors "should be skeptical about prescribing evolocumab for patients with established atherosclerotic cardiovascular disease."
In a note for Barclays published Tuesday morning, analyst Carter Gould, who has an underweight rating on shares and $234 price target (~11% downside based on Friday's close) said the development could impact long-term estimates of Repatha sales.
Read The Value Portfolio's assessment of Amgen's (AMGN) recent ~$28B acquisition of Horizon Therapeutics.