Those benefits are clinically significant, not just statistically significant, and in a conference call hosted by Mizuho Securities USA Inc.’s senior biotech analyst Salim Syed, James Underberg, a clinical assistant professor of medicine at New York University Medical School and president-elect of the national lipid association, stressed the good news about the results. It cut the risk of stroke by 21%.
Prof Sever added: “They would have another 20 percent reduction in risk and that is a big effect”. Nevertheless, he said that this drug did not reduce deaths.
Amgen shares, which closed Thursday at $180.11, could face selling pressure Friday.
“Namely we have a new, safe way to lower cholesterol and heart attack risks that works on top of statins“. Insurance companies have been trying to escape costly Repatha and have asked the company to provide better proof of reduction in heart disease risk.
“At a cost of $7K/year, this translates to $958K per event saved”, Gal wrote.
Results from the highly anticipated 27,564-patient Fourier study should help remove some barriers to patient access from health insurers and pharmacy benefit managers, who have been rejecting some 75 per cent of prescriptions written for the costly medicine. The new drug, Amgen’s Repatha, lowers cholesterol more and is given as shots every two weeks or once a month.
In the absence of cardiovascular outcomes data, insurance companies have balked at that price tag.
This last result is something insurers care about – preventing costly health care.
Now, payers no longer have that excuse.
“We were anxious that maybe the soft endpoint would be driving the data”.
The Medicines Company plans to push its PCSK9 synthesis inhibitor into “aggressive” Phase 3 development, including a cardiovascular outcomes trial, after complete results from a mid-stage study released Friday showed competitive LDL cholesterol-lowering ability. Some cardiologists and researchers had anxious that very low LDL might have deleterious effects, just as excessively low blood pressure can.
Experts said the findings were the most important since the first statins trials two decades ago. “We really should be trying to get it as low as possible”. Inhibiting the protein can cause the level of LDL, or “bad” cholesterol, to tumble dramatically to unheard-of levels – from 92 milligrams per deciliter to 30 milligrams. MDCO believes that nothing has come out of this trial which will turn off the FDA on approving drugs on LDL, since AMGN got what one would expect on both modifiable and non-modifiable endpoints alike.
The benefits increased over time, with patients who took the combined treatments roughly 19 per cent less likely to suffer a heart attack or stroke in their first year, and 33 per cent in the second. Even though these patients were optimally treated with the latest therapies, they were still at high risk for an additional cardiac event.
“We did not find evidence for decline in neurocognitive function after almost two years od treatment with evolocumab using a dedicated series of neuropsychological tests”. The key secondary endpoint was the time to cardiovascular death, myocardial infarction, or stroke.
The randomized trial involved 27,564 people who had experienced a prior heart attack or stroke, or who had significantly clogged arteries that limited blood flow to their limbs.
Safety-wise, Repatha patients didn’t see some of the side effects that other lipid therapies produce, he said.
Meanwhile, another study is underway to test a similar drug called Praluent, and see whether it too lowers heart risks.
Repatha shots are given once or twice in a month while patients take statins regularly. All the patients were taking cholesterol-lowering statins, most at high doses.