Amgen's Repatha shows durable treatment effect in long-term study

The results of all analyses were presented at the American Heart Association's Scientific Sessions 2018 in Chicago.

Amgen Headquarters

Singapore – Amgen announced the final results from a five-year open-label study evaluating the ability of Amgen's Repatha (evolocumab) to lower "bad" cholesterol (LDL-C) in patients with hypercholesterolemia showed a sustained treatment effect.

In an effort to help more patients bring down the risk of heart attack and stroke, Amgen recently made Repatha available in the United States (U.S.) at a 60 percent reduced list price to address concerns over high out-of-pocket costs for patients. The results of all analyses were presented at the American Heart Association's Scientific Sessions 2018 in Chicago.

At the end of the first year of treatment, patients receiving Repatha achieved a 59% reduction in average LDL-C from baseline. In years two, three, four and five, the mean reductions were 56%, 57%, 56% and 56%, respectively.

On the safety front, the rates of serious adverse events were consistently around 7%.

"Amgen is pleased to present the results of OSLER-1, the longest study of a PCSK9 inhibitor to date, which clearly demonstrate the durable, long-term efficacy and safety of Repatha in reducing LDL-C levels," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "These findings are consistent with those observed in the Repatha cardiovascular outcomes study (FOURIER) and other Phase 3 trials, reinforcing Repatha's role in the treatment of high-risk patients who are unable to achieve sufficient LDL-C reduction through other means."

The FDA approved Repatha in August 2015 for patients with high cholesterol.

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