Anti-cholesterol drug Praluent cuts death risk

Laverne Higgins
March 13, 2018

The study also showed that Praluent caused a reduction in all-cause death.

As federal officials struggle to tackle exorbitant pharmaceutical prices, at least one drug's manufacturers have pledged to slash prices of a potentially life-saving drug for its most at-risk patients. That group saw a 29 percent reduction in death from any cause after taking the drug for two years. A price of $4,500 to $8,000 per year would be justified for patients at higher risk, with LDL over 100.

For those in the Praluent treatment arm, approximately 75% of patient time was on the 75 mg dose.

The drug was deemed extremely safe with no difference from placebo in incidence of neurocognitive problems or new-onset diabetes. It's the first study with a PCSK9 inhibitor to show an associated mortality benefit, researchers said.

And for patients at the highest risk - LDL, or "bad" cholesterol, of 100 mg/dL or higher - had a 24 percent reduction in cardiovascular events, including heart attack and stroke, compared with the placebo. "In this trial, such patients who received Praluent on top of maximally-tolerated statins had important reductions in their risk".

Despite the widespread use of statins, heart disease remains the leading cause of death, according to the Centers for Disease Control and Prevention. Regeneron will now focus its commercial efforts on those patients, and plans to reach out to payers with a deal: provide "straightforward access for high-risk patients", and it will lower the price of alirocumab, according to a press release.

The trial was funded by Sanofi and Regeneron Pharmaceuticals.

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Other worldwide numbers available here (https://media.choruscall.ch/documents/Attended_DI_numbers.pdf). The trial included those whose LDL cholesterol remained 70 mg/dL or above, non-HDL cholesterol 100 mg/dL or above, or apolipoprotein B 80 mg/dL or above despite treatment with a high or maximum-tolerated dose of a high-potency statin (atorvastatin or rosuvastatin).

Alirocumab inhibits the binding of proprotein convertase subtilisin/kexin type 9 (PCSK9) to the LDL receptor and thus heightens the number of available LDL receptors on the surface of liver cells.

In the U., Praluent is approved for use as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease who require additional lowering of LDL-C.

In the European Union, Praluent was approved for treating adults with primary hypercholesterolemia or mixed dyslipidemia as an adjunct to diet with certain conditions attached.

However, the drug had been approved in the USA 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. This will allow quick identification of new safety information.

The effect of Praluent on cardiovascular morbidity and mortality has not been determined. Founded and led by physician-scientists for 30 years, our unique ability to repeatedly and consistently translate science into medicine has led to six FDA-approved treatments and over a dozen product candidates, all of which were homegrown in our laboratories. Patients give themselves shots of the medicine once or twice a month.

Alirocumab is a fully human monoclonal antibody that works by blocking PCSK9.

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