Active Wall St. blog coverage looks at the headline from Amgen Inc. (NASDAQ: AMGN) as the Company announced on May 20, 2017, that new data were available from the Repatha® (evolocumab) cardiovascular outcomes trial have demonstrated that Repatha consistently and safely reduced cardiovascular events in patients with established cardiovascular disease regardless of baseline low-density lipoprotein cholesterol (LDL-C) level below or above 70 mg/dL. Repatha is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). 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. Register with us now for your free membership and blog access at:
One of Amgen’s competitors within the Biotechnology space, Incyte Corporation (NASDAQ: INCY), reported on May 04, 2017, its financial results for Q1 2017, and provided updates on key clinical programs. AWS will be initiating a research report on Incyte in the coming days.
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Repatha Cardiovascular Outcomes (FOURIER) Study Design
The Company’s Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk (FOURIER) is a 27,564-patient, multinational Phase 3 randomized, double-blind, placebo-controlled trial, designed to evaluate whether treatment with Repatha in combination with statin therapy compared to placebo plus statin therapy reduces cardiovascular events. The primary endpoint was time to cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization. The secondary endpoint for the trial was the time to cardiovascular death, myocardial infarction, or stroke.
Amgen stated that in patients with a baseline LDL-C below 70 mg/dL, Repatha reduced the median baseline LDL-C from 65.5 mg/dL to 21.0 mg/dL. Repatha consistently reduced the risk of the composite primary endpoint, which included hospitalization for unstable angina, coronary revascularization, heart attack, stroke or cardiovascular death, regardless of whether baseline LDL-C was below or above 70 mg/dL. The results were also consistent for the secondary composite endpoint of heart attack, stroke or cardiovascular death where patients with a baseline LDL-C less than 70 mg/dL experienced a 30% reduction in cardiovascular events and patients with a baseline LDL-C greater than or equal to 70 mg/dL experienced a 19% reduction in cardiovascular events.
In patients on maximum-intensity statins, Repatha reduced the median baseline LDL-C from 93 mg/dL to 32 mg/dL. Additionally, Repatha consistently reduced the risk of major cardiovascular events in patients on maximum-intensity and less intense statin therapy in both the composite primary endpoint.
In the two analyses, there were no differences in the rates of adverse events leading to discontinuation between treatment groups in patients who had a baseline LDL-C below 70 mg/dL or in patients on maximum-intensity statin therapy.
No new safety concerns were identified in this large clinical trial with roughly 60,000 patient-years of follow-up; this included the assessment of patients who achieved very low levels of LDL-C.
“These results provide further evidence for patients with established cardiovascular disease who would otherwise be considered as being successfully managed to the most stringent treatment targets,” said Sean E. Harper, M.D., Executive Vice President of Research and Development at Amgen.
At the closing bell, on Monday, May 22, 2017, Amgen’s stock slipped 2.23%, ending the trading session at $153.02. A total volume of 6.91 million shares were traded at the end of the day. In the last six months and previous twelve months, shares of the Company have advanced 3.84% and 1.89%, respectively. Moreover, the stock gained 4.66% since the start of the year. The stock is trading at a PE ratio of 14.50 and has a dividend yield of 3.01%. The stock currently has a market cap of $113.57 billion.