Regeneron's anti-cholesterol drug Praluent reduces death risk in trial

The anti-cholesterol drug Praluent (alirocumab), made by France's Sanofi Pharmaceuticals, is linked to a 15 percent lower risk of major cardiovascular events like heart attack and stroke, a study said Saturday. This action of the drug allows the liver to remove more LDL from the blood and lowers the concentration of LDL cholesterol in the blood.

The cost of PCSK9 inhibitors, which also include Amgen's Repatha, is more than $14,000 per year, according to the Institute for Clinical and Economic Review, which has raised concern about their availability to those who need them.

Regeneron and Sanofi's move to adopt ICER's recommended price range reflects the growing scrutiny of drug costs, and calls for pharmaceutical companies to price their products according to their value to patients, rather than what the market will bear, ICER President Steven D. Pearson said in an interview.

Regeneron is accelerating and improving the traditional drug development process through its proprietary VelociSuite technologies, including VelocImmune to yield optimized fully-human antibodies, and ambitious initiatives such as the Regeneron Genetics Center, one of the largest genetics sequencing efforts in the world. "I hope this particular study really is a trigger for making this drug much more available to people who need it". "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.

The benefit was even greater among those with stubbornly high "bad", or LDL cholesterol, above 100 mg/dL.

The Odyssey Outcomes trial, which met its primary endpoint, was held in almost 19,000 patients who had a recent acute coronary syndrome (ACS) event, such as a heart attack. Some patients who switched to 150 mg switched back to 75 mg if their LDL-C fell below 25 mg/dL (n=805), and patients who experienced two consecutive LDL-C measurements below 15 mg/dL while on the 75 mg dose (n=730) stopped active Praluent therapy for the remainder of the trial. Compared with FOURIER, the ODYSSEY Outcomes trial enrolled a higher-risk group of patients, had a longer duration of follow-up (ranging from two to five years), involved a different dosing strategy and had a slightly different primary endpoint. Despite their striking ability to lower gobs of LDL-C or "bad" cholesterol, their sales have been meager compared to Wall Street analysts' initial bullish multi-billion dollar projections; alirocumab tallied $194 million past year worldwide, evolocumab $319 million.

A trial of the drug presented at the American College of Cardiology's annual scientific session showed it was more effective in preventing heart attack, stroke and all-cause mortality than a placebo, but physicians are still puzzled by access barriers to alirocumab and evolocumab, another PCSK9 inhibitor.

A first outcomes trial past year, called Fourier, similarly reported that Repatha, a different PCSK9 inhibitor called evolocumab, reduced the risk of death, heart attack, stroke, hospitalization for angina or revascularization procedures. It's the first study with a PCSK9 inhibitor to show an associated mortality benefit, researchers said.

The manufacturers were pleased with the results, suggesting there may be more people who can benefit from them - including with conversation about the high cost of the drugs. A price of $4,500 to $8,000 per year would be justified for patients with LDL over 100, the group said.

(Copyright © 2015. All Rights Reserved.)

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