
US biotech Amgen (Nasdaq: AMGN) has reported that its cholesterol therapy Repatha (evolocumab) hit both primary endpoints in the Phase III Vesalius-CV trial, reducing the risk of major adverse cardiovascular events (MACE) in patients without a prior history of heart attack or stroke.
The late-stage trial tracked more than 12,000 high-risk patients over four and a half years, most of whom were already receiving high- or moderate-intensity statins or similar LDL-C lowering therapy. Amgen said the results were both clinically- and statistically-significant, with no new safety concerns.
“These results mark an important milestone in the fight against cardiovascular disease, the leading cause of death worldwide,” said Jay Bradner, executive vice president of research and development at Amgen. He added that Repatha “is now the first and only PCSK9 inhibitor shown to reduce cardiovascular events in high-risk adults without prior heart attack or stroke.”
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