Amgen (AMGN) Announced a New Analysis From the Repatha® (evolocumab)

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New Repatha® (evolocumab) Analysis Demonstrates Cardiovascular Outcomes Efficacy And Safety Of Achieving Very Low LDL-C Levels

Data Supports Lower LDL-C Levels for High-Risk Cardiovascular Patients

Simultaneously Presented at ESC 2017 and Published in The Lancet

Amgen (AMGN) today announced a new analysis from the Repatha® (evolocumab) cardiovascular outcomes study (FOURIER) that showed a statistically significant relationship between lower achieved low-density lipoprotein cholesterol (LDL-C) levels and lower cardiovascular event rates in patients with established atherosclerotic cardiovascular disease. There was no evidence of a leveling off of effect and no new safety concerns were identified in this analysis. The results were presented today in a Late-Breaking Clinical Trials session at the European Society of Cardiology (ESC) Congress 2017 in Barcelona, Spain and simultaneously published in The Lancet.

“With this analysis, we’ve further demonstrated the safety and efficacy of achieving an LDL-C well below current targets,” said Robert P. Giugliano, M.D., S.M., Brigham and Women’s Hospital and Harvard Medical SchoolBoston and lead author on the analysis. “These findings from the first analysis of a large cohort of patients to achieve such ultra-low LDL-C levels support the use of intensive lipid-lowering therapies, such as the combination of evolocumab and statin therapy, in high-risk patients to safely reduce the risk of another cardiovascular event.”

Approximately 26,000 patients from the Repatha cardiovascular outcomes study were followed for a median of 2.2 years and stratified post-randomization into five prespecified groups irrespective of treatment allocation based on achieved LDL-C at week four from baseline: <0.5 mmol/L (which converts to less than 20 mg/dL), 0.5-<1.3 mmol/L, 1.3-<1.8 mmol/L, 1.8-<2.6 mmol/L, and ≥2.6 mmol/L (see footnote for conversions of all groups to mg/dL). Rates for the primary and secondary composite endpoints and cognitive function testing, as well as safety events, including cancer, hemorrhagic stroke, new onset diabetes, cataract, neurocognitive dysfunction and non-cardiovascular death were compared across these five groups.

The analysis demonstrated that there was a highly significant progressive relationship between lower LDL-C and a lower risk of the primary composite endpoint (ptrend<0.0001). A similar progressive reduction in the key secondary composite endpoint, which included heart attack, stroke or cardiovascular death, was also observed across all five groups (p=0.0001 for a monotonic relationship). There was no meaningful difference in the safety profile across the five groups, including the group with the lowest achieved LDL-C level. Lastly, patients were more likely to achieve very low LDL-C levels when treated with Repatha and statin therapy versus statin alone.

“Scientific evidence demonstrating the strong progressive association between lowering LDL-C and the risk reduction of cardiovascular events in patients with established atherosclerotic cardiovascular disease continues to grow,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “For patients who have already experienced an event, such as a heart attack or stroke, this analysis reinforces that the intensive LDL-C lowering provided with Repatha helps patients reduce their risk of another cardiovascular event.”

Relationship of Achieved LDL-C and Primary and Secondary Efficacy Composite Endpoints
The risk of the primary composite efficacy endpoint, which included cardiovascular death, heart attack, stroke, coronary revascularization or hospitalization for unstable angina, was progressively lower as the achieved LDL-C at week 4 was reduced.

Based on Kaplan-Meier event rates at three years, Repatha reduced the risk of the composite primary endpoint across all five groups (24 percent in patients with LDL-C <0.5 mmol/L; 15 percent in patients with LDL-C of 0.5-<1.3 mmol/L; 6 percent in patients with LDL-C of 1.3-<1.8 mmol/L; and 3 percent in patients with LDL-C of 1.8-<2.6 mmol/L, using the group with LDL-C ≥2.6 mmol/L as the referent [ptrend<0.0001]).

In a post-hoc analysis, 504 patients who achieved an LDL-C of less than 0.26 mmol/L, or 10 mg/dL, experienced a 31 percent risk reduction in the primary composite endpoint (p=0.035)  and a 41 percent risk reduction in the secondary composite endpoint (p=0.020).

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