Therapy Areas: Inflammatory Diseases
Repatha (evolocumab) Reduces Cardiovascular Events in Patients with PAD or History of Heart Attack
14 November 2017 - - Thousand Oaks, California-based human therapeutics developer Amgen (NASDAQ: AMGN) has released five new subgroup analyses from the Repatha (evolocumab) cardiovascular outcomes study (FOURIER) that showed the addition of Repatha to statin therapy improved clinical outcomes with significant reduction of cardiovascular (CV) events, such as heart attack and stroke, in high-risk patients with peripheral artery disease (PAD), and in patients with a history of heart attack, the company said.
One analysis showed the addition of Repatha to statin therapy improved clinical outcomes with significant reduction of CV events in patients with a history of PAD. Because of their greater baseline risk of CV events, there was a numerically greater absolute risk reduction at 2.5 years in patients with PAD (ARR 4.1%, 95% CI 2.5-6.7) relative to those without PAD (ARR 1.5%, 95% CI 0.7-2.2).
A separate analysis investigated the efficacy of Repatha in high-risk patients who have experienced a prior heart attack.
In that analysis, the ARR was greater (~3% ARR over three years) in patients with a history of heart attack within two years compared to those whose heart attack was more than two years past (ARR 1%).
No new safety concerns were identified in these analyses.
Repatha (evolocumab) is a human monoclonal antibody that binds to proprotein convertase subtilisin/kexin type 9 (PCSK9) and inhibits circulating PCSK9 from binding to the low-density lipoprotein receptor (LDLR), preventing PCSK9-mediated LDLR degradation and permitting LDLR to recycle back to the liver cell surface. By inhibiting the binding of PCSK9 to LDLR, Repatha increases the number of LDLRs available to clear low-density lipoprotein from the blood, thereby lowering circulating LDL levels.
Repatha is approved in more than 50 countries, including the US, Japan, Canada and in all 28 countries that are members of the European Union. Applications in other countries are pending.
Amgen is dedicated to advancing care and improving the lives of patients with cardiovascular disease, the leading cause of morbidity and mortality worldwide. 
The company's research utilizes human genetics to identify and validate certain drug targets. Through its own research and development efforts, as well as partnerships, Amgen is building a robust cardiovascular portfolio consisting of several approved and investigational molecules.
Amgen discovers, develops, manufactures, and delivers human therapeutics worldwide. It offers products for the treatment of illness in the areas of oncology/hematology, cardiovascular, inflammation, bone health, nephrology, and neuroscience.
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