The PCSK9 inhibitor, which lowered blood lipids by 40-60% in previous trails, reduced the risk of MACE by 15% and was associated with a 29% lower risk of death overall in a patient population with acute coronary syndrome.
Last year, researchers reported similar results for a different PCSK9 inhibitor called Repatha (evolocumab), made by Amgen Pharmaceuticals, which also cut the risk of heart attack, stroke, and hospitalization for blocked arteries by 15 percent. The study also showed that Praluent caused a reduction in all-cause death.
The news comes as the high price of prescription drugs remains a big political flashpoint; both new U.S. Health and Human Services Secretary Alex Azar and FDA Commissioner Scott Gottlieb amped up the pressure on drug companies, hospitals, and insurers this week to change payment schemes and increase drug price transparency to help drive down healthcare costs. Importantly, no significant safety signals were seen across the study of nearly 19,000 patients.
The drug was deemed extremely safe with no difference from placebo in incidence of neurocognitive problems or new-onset diabetes. The discount deal would apply only to patients with dangerously high levels of cholesterol who are at especially high risk for heart attack or stroke.
"Not all patients with heart disease are the same". "Through this trial, we have been able to identify high-risk patients treated with optimal statins who still have an urgent need for additional treatment options". Regeneron will now focus its commercial efforts on those patients, and plans to reach out to payers with a deal: provide "straightforward access for high-risk patients", and it will lower the price of alirocumab, according to a press release.