Put those two stats together, and Repatha patients saw a 19% reduction in risk for the first year and 33% after that, SVP of global development Elliott Levy said in an interview.
Amgen, Inc. shares fell $12.71 (-7.06%) in Friday morning trading.
“The barriers that have been thrown up by the payers have been around, ‘You don’t have outcomes data, ‘” said Dr. Sean Harper, Amgen’s head of R&D. Insurers are naturally reluctant to pay for the drug without evidence is protects high-risk patients from heart attacks and strokes.
“Now, with strong outcomes data, I’m hopeful that the marketplace will appreciate these data and allow practitioners to prescribe these drugs in an economically favorable way”, Kuvin said.
The Amgen study, known a FOURIER, did demonstrate a statistically significant cardiovascular benefit for patients treated with Repatha, part of a new class of injected cholesterol lowering drugs known as PCSK9 inhibitors.
The sell-off Friday on Esperion Therapeutics (ESPR) stock in light of Amgen’s (AMGN) heart study results was unwarranted, an analyst said, arguing that Esperion’s drug will likely be priced much lower.
Until today, insurance companies had said no.
A year and a half after its feted approval, a new cholesterol drug has passed a key test.
About 11 million Americans could be eligible for Repatha, according to Amgen.
In an effort to ease insurers’ concerns, Amgen also announced in the study’s press release that it plans to offer “additional contracting options” to US payers that are willing to remove restrictions on accessing Repatha. The company believes the study results meet that goal.
Doctors often recommend that people keep their LDL levels under 100 milligrams per deciliter, and that people at very high risk reduce their LDL under 70.
For this reason, the relative risk reduction was greater as assessed by the secondary endpoint, which focused on more serious adverse events. The FDA approved Repatha and Regeneron Pharma’s (REGN) Praluent on that basis.
Nearly 14,000 patients were recruited to the treatment arm of the study, receiving the drug over a 48-week period.
Patients treated with evolocumab experienced a 27% reduction in the risk of heart attack (P 0.001), a 21% reduction in the risk of stroke (P = 0.01), and a 22% reduction in the risk of coronary revascularization (P 0.001) compared with those given placebo. Like many newly developed medications, they are incredibly expensive, costing as much as $16,000 per year, and they require receiving an injection every two to four weeks for the rest of your life. The FOURIER trial (Further Cardiovascular OUtcomes Research with PCSK9 Inhibition in subjects with Elevated Risk) was created to determine whether evolocumab, when added to statin therapy, would reduce adverse cardiovascular events.
Dr Marc Sabatine, from Brigham and Women’s Hospital in MA and lead researcher on the study, will present the findings today (17th March) at the American College of Cardiology’s (ACC) 66th Annual Scientific Session in Washington.
A new drug can prevent heart attacks and strokes by cutting bad cholesterol levels, scientists have found.
“They would have another 20 percent reduction in risk, and that is a big effect”, Prof Sever said. These patients came into the trial with established atherosclerotic CV disease, those who’d had a heart attack or stroke, or peripheral artery disease.
The investigators who conducted the FOURIER study noted Repatha’s benefit grows over time.
What is not talked about as much is that nearly all of the statins are now generic and cheap.
Weiss, the UCSF cardiologist, takes issue with Amgen’s interpretation of the Repatha data. The median duration of follow-up was 2.2 years.
“The trial really validates the LDL hypothesis and it proves that lower is better”, Levy said, adding that Fourier “answers the extremely important longstanding question-how low should it go?”
The evolocumab study was funded by Amgen, the pharmaceutical company that makes the drug, which is marketed as Repatha.