Regeneron, Sanofi To Cut Heart Drug's Price; Say Praluent Lowers Risk Of Death

(RTTNews) - Sanofi (SNY) and Regeneron Pharmaceuticals Inc. (REGN) announced that the ODYSSEY OUTCOMES trial met its primary endpoint, showing Praluent (alirocumab) Injection significantly reduced the risk of major adverse cardiovascular events (MACE) in patients who had suffered a recent acute coronary syndrome (ACS) event such as a heart attack.

On the primary endpoint, Praluent reduced the overall risk of MACE by 15%. Praluent was also associated with a lower risk of death overall, known as "all-cause mortality", and there were also numerically fewer coronary heart disease (CHD) deaths.

In a pre-specified analysis, the patients with baseline LDL-C levels at or above 100 mg/dL experienced a more pronounced effect from Praluent, reducing their risk of MACE by 24%. In a post-hoc analysis of this group, Praluent was associated with a lower risk of death from any cause by 29%.

There were no new safety signals in the trial, with injection site reactions experienced more commonly in the Praluent group compared to patients on maximally-tolerated statins alone. There was no difference in neurocognitive events or new-onset diabetes.

Separately, Sanofi and Regeneron Pharma announced plans to make Praluent more accessible and affordable for patients with the greatest health risk and unmet need.

For U.S. payers willing to reduce access barriers for high-risk patients, companies will offer net price within a cost-effective range, leveraging a new ICER analysis.

The companies will take a precision medicine approach focusing efforts on high-risk patients, such as those who have had heart attacks or unstable angina and cannot reduce their LDL-C below 100 mg/dL despite maximally-tolerated statin therapy.