Regeneron and Sanofi's Praluent successful in large-scale cardiovascular outcomes study

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It's the first time a cholesterol-lowering drug has reduced deaths since statins such as Lipitor and Crestor came out decades ago. "It is remarkable that such a potent intervention is also so safe", Dr. Philippe Gabriel Steg, chief of cardiology at Bichat Hospital in Paris and co-chairman of the study, said in an ACC press release.

"That's a high cost" that may still hinder its use, said one independent expert, Dr Amit Khera, a preventive cardiologist at UT Southwestern Medical Center in Dallas and a spokesman for the American Heart Association.

However, the drug had been approved in the U.S. as an adjunct to diet and maximally-tolerated statin therapy for adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) who need further lowering of LDL-C. Statins are the main medicines for this, but some people can't tolerate or get enough help from them.

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All told, the data will be important for Sanofi to grow Praluent's uptake against Amgen's market-leading Repatha in a class that's already far behind initial projections, largely because of payer barriers.

Investigators followed the patients for an average of 33 months.

And in an unusual move, Regeneron-based on input from the nonprofit drug-pricing watchdog, the Institute for Clinical and Economic Review (ICER)-vows to cut the cost of the drug if it can get certain concessions from insurers. The study is the second of its kind-following a similar, 27,564-patient trial from Amgen past year.

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Now, Sanofi and Regeneron have laid down the gauntlet to their rival, saying they will "offer USA payers that agree to reduce burdensome access barriers for high-risk patients a further reduced net price for Praluent ... in alignment with a new value assessment for high-risk patients".

All had LDL over 70 despite maximum statin use. Praluent slashed bad cholesterol by more than half after four years.

With an LDL target range of 25-50, rather than taking it as low as possible, three-quarters of patients ended up on a lower dose of Praluent and some were taken off the drug if their LDL remained at 15 or lower.

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The trial succeeded on its primary goal - reducing the combined risk of heart attack, stroke, heart disease-related death and chest pain requiring hospitalization - by 15 percent. Benefits were greater for those whose LDL was 100 or more at the start of the study. The result is that the vast majority of patients prescribed the drug don't actually fill their prescription, says Regeneron CEO Leonard Schleifer. The high-risk group is the estimated 1.3 million people in the USA and Europe who have had heart attacks or strokes and still can't get their LDL-C levels below 100 mg/dL of blood despite treatment with statins. This appears to be the main driver behind their plan to discount the medication for high-risk patients. If the drugs were used more broadly to treat all patients included in the trial, the cost-effective price would be in a range of $2,300 to $3,400 annually, ICER said. While there's a benefit for all patients, the investigators honed in on the highest-risk group because of the chance to make a difference for patients, he said.

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