13 March 2018 - - Paris, France-based human health-focused biopharmaceutical company Sanofi (EURONEXT: SAN; NYSE: SNY) and Tarrytown, New York-based serious medical conditions treatment developer Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) have presented results of the 18,924-patient, long-term ODYSSEY OUTCOMES trial at the American College of Cardiology's 67th Annual Scientific Session, the companies said.
The trial met its primary endpoint, demonstrating that high-risk patients who added Praluent (alirocumab) Injection to maximally-tolerated statins experienced significantly fewer major adverse cardiovascular events compared to those on maximally-tolerated statins alone.
Praluent was also associated with a lower risk of death from any cause, and a more pronounced effect was observed in patients with baseline LDL-C levels at or above 100 mg/dL despite maximally-tolerated statins.
In this group, Praluent reduced risk of major adverse cardiovascular events by 24% and was associated with a 29% lower risk of death overall.
The safety profile of Praluent was consistent with previous trials and no new safety issues were observed. Injection site reactions were experienced more commonly in the Praluent group compared to patients on maximally-tolerated statins alone (3.8% Praluent; 2.1% placebo).
Praluent inhibits the binding of PCSK9 (proprotein convertase subtilisin/kexin type 9) to the LDL receptor and thereby increases the number of available LDL receptors on the surface of liver cells, which lowers LDL-C levels in the blood.
Regeneron is a biotechnology company that invents life-transforming medicines for people with serious diseases.
It has six FDA-approved treatments and over a dozen product candidates designed to help patients with eye disease, heart disease, allergic and inflammatory diseases, pain, cancer, infectious diseases and rare diseases.