LONDON, Mar 17 (APM) - Amgen said on Friday a major trial shows Repatha dramatically reduces risk of heart attack and stroke, but the U.S. pharma's shares plunged 7% as analysts said the results did not meet expectations.
Amgen said in a statement that the 27,564-patient Repatha (evolocumab) cardiovascular outcomes study, FOURIER established for the first time that maximally reducing low-density lipoprotein cholesterol (LDL-C) levels with Repatha, beyond what is possible with the current best therapy alone, leads to a further reduction in major cardiovascular events, including heart attacks, strokes and coronary revascularisations.
The study was statistically powered around the hard major adverse cardiovascular event (MACE) composite endpoint of first heart attack, stroke or cardiovascular death and found that adding Repatha to optimised statin therapy resulted in a statistically significant 20% reduction in these events.
The robust benefit in this objective measure started as early as six months and continued to accrue through the median 2.2 years of the study, said Amgen. In fact, the magnitude of the risk reduction in the hard MACE composite endpoint grew over time, from 16% in the first year to 25% beyond the first year.
The study also found a statistically significant 15% reduction in the risk of the extended MACE composite primary endpoint, which included hospitalisation for unstable angina, coronary revascularisation, heart attack, stroke or cardiovascular death.
Patients on Repatha experienced a 27% reduction in the risk of heart attack , 21% for stroke and 22% for coronary revascularisation. Consistent with recent trials of more intensive LDL lowering, there was no observed effect on cardiovascular mortality.
Similarly, there was no observed effect on hospitalisation for unstable angina. In an exploratory analysis, the relative risk reduction for fatal and non-fatal heart attack or stroke was 19% in the first year and 33% beyond the first year.
Dr Ethan Weiss, a cardiologist and associate professor of medicine at the Cardiovascular Research Institute, was quoted online in the press on Friday as saying: "These Repatha results are disappointing. A 15% relative reduction in risk for the primary endpoint is much lower than predicted based on prior trials.
"The top line here is that for this population, it is going to be hard to justify the cost of these [PCSK9] medicines for the magnitude of the risk reduction."
Other analysts said that insurance companies would need to see risk reductions of at least 20% but possibly 25%.
Dr Marc Sabatini, chairman of the TIMI Study Group at the at Brigham and Women's Hospital, and professor of medicine, Harvard Medical School, Boston, was more positive, saying: "We now show for the first time in a dedicated outcomes study that decreasing LDL cholesterol with PCSK9 inhibition results in clinically meaningful cardiovascular benefit.
"These benefits were achieved with lowering LDL cholesterol down to a median of 30 mg/dL, which is well below current targets, and the magnitude of risk reduction increased the longer patients were on therapy. These results support the need for long-term, vigorous LDL cholesterol reduction in our patients with cardiovascular disease."
When added to statin therapy, Repatha reduced LDL-C from a median of 92 to 30 mg/dL, a reduction of 59% at week 48, which was sustained throughout the trial. At 48 weeks, the LDL-C was reduced to at least 25 mg/dL in 42% of patients treated with Repatha, as compared with less than 0.1% in the placebo group.
Amgen's head of research and development Dr Sean Harper said: "This is a game changer for high-risk patients. Even though these patients were optimally treated with the latest therapies, they were still at high risk for an additional cardiac event. It's remarkable to see such a large impact in reducing cardiac events given that this patient population was only on Repatha for about two years.
"The absolute benefit will be even greater than what we observed in the Repatha outcomes trial, since the cardiovascular event rate in clinical practice is about two to three times higher than what is typically reported in a rigorously controlled outcomes trial."
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