Sanofi and Regeneron Pharmaceuticals Inc.'s cholesterol medicine Praluent reduced the risk of heart attacks and other major acute cardiovascular events by 15% in a more than 18,000-patient trial dubbed Odyssey.
The companies will work to make the drug, which retails wholesale for more than $14,000, more accessible and affordable to high-risk patients, the companies said in a joint statement following the results.
The findings were presented at the annual American College of Cardiology meeting on Mar. 10. The cardiovascular events measured, known by the acronym MACE, included heart attack, ischemic stroke, death from coronary heart disease or plaque buildup in the artery that required hospitalization.
The overall MACE reduction rate mirrors the 15% rate seen in a trial for rival Amgen Inc.'s Repatha that was presented at the cardiology meeting last year. Both drugs are PCSK9 inhibitors, a new class of cholesterol therapy that has been met with some resistance from payers who expect greater effectiveness before switching patients over from older, cheaper drugs called statins.
Praluent showed a slightly lower overall risk of death from cardiovascular events, but demonstrated most effectiveness among patients with the highest level of a lipoprotein known as LDL-C that is associated with bad cholesterol. Patients with LDL-C levels at or above 100 milligrams per deciliter showed a 24% reduced risk of MACE in the trial.
There were no significant safety risks associated with Praluent, beyond more injection site reactions than in the statin group of the trial.
At the same time as the Odyssey results, Regeneron and Sanofi said that they shared the study's findings with U.S. price watchdog the Institute for Clinical and Economic Review ahead of today's presentation at the conference.
The institute, which has called for PCSK9 price cuts before, said that based on the study, the therapies should retail for $4,500 to $8,000 a year for the high-risk set and $2,300 to $3,400 a year for other patients.
Regeneron CEO Len Schleifer has spoken out about payer barriers to PCSK9 therapies, saying in the company's latest earnings call that "payers are making it very tough for doctors to fill out the forms."
Praluent made $195 million in 2017, almost entirely from U.S. sales. Repatha made $319 million in the year.
Amgen, meanwhile, has funded a series of studies into the drugs' cost-effectiveness and payer barriers to coverage, suggesting in research presented a day earlier at the cardiology meeting that 110,000 cardiovascular events could have occurred over the course of a year in patients whose insurers would not pay for one of the therapies.