Sanofi and Regeneron have pledged to make Praluent more accessible to patients as data show that the drug significantly cut the risk of cardiovascular events in high-risk patients.
Data from the ODYSSEY OUTCOMES trial presented at the American College of Cardiology's annual scientific session (ACC) show that high-risk patients who added Praluent (alirocumab) Injection to maximally-tolerated statins experienced significantly fewer major adverse cardiovascular events (MACE) compared to those on maximally-tolerated statins alone.
Praluent reduced the overall risk of MACE - which includes heart attack, ischemic stroke, death from coronary heart disease (CHD), or unstable angina requiring hospitalisation - by 15 percent, and was also linked with a lower death risk of death overall, the firms noted.
Patients with higher baseline LDL-C levels (at or above 100 mg/dL) experienced a more pronounced effect from the drug, which reduced the risk of MACE by 24 percent, and cut the risk of death from any cause by 29 percent.
"Many patients who have survived a recent heart attack or other coronary event are unable to reach an LDL cholesterol goal of less than 100 mg/dL, and have an urgent need for new therapeutic options because of their increased risk of another event. In this trial, such patients who received Praluent on top of maximally-tolerated statins had important reductions in their risk,” commented George Yancopoulos, president and chief scientific officer at Regeneron.
“With nearly 90 percent of the patients in this trial on high-intensity statins, the data demonstrate that a precision-medicine approach in the field of cardiovascular disease may further advance how we better treat high-risk patients," added Elias Zerhouni, president, Global R&D, Sanofi.
Alongside the data the companies announced plans to boost the affordability and accessibility of Praluent for patients most in need, by offering a reduced net price to US payers that agree to reduce “burdensome access barriers” for high-risk patients.
The intention is to take a precision medicine approach to addressing the burden of cardiovascular disease, by focusing efforts on high-risk patients most vulnerable for future CV events, such as those who have suffered a previous event and are unable to reduce their LDL cholesterol (LDL-C) below 100 mg/dL despite statin therapy.
“Inventing innovative medicines only matters if the people who need these products are able to access them - and that is unfortunately not the case with Praluent today,” said Leonard Schleifer, president and chief executive of Regeneron.
“We believe a new paradigm is needed in how all members of the healthcare community collaborate to ensure that patients are able to affordably access medical treatments they need.
“We hope that our unprecedented approach to collaborating with payers and other stakeholders demonstrates that it is possible to bring major innovation to patients at a price that aligns with the value delivered.”