New Cholesterol Drug Effective but Expensive

New Cholesterol Drug Effective but Expensive

The two companies immediately announced that they were willing to offer price breaks on the costly medication.

The study tested the injected biotech drug versus placebo in almost 19,000 patients who had a recent heart attack or severe chest pain episode and were already on maximum doses of cholesterol-lowering statins, such as Pfizer's Lipitor.

The companies will meet with United States healthcare providers to to discuss potential net pricing adjustments for those that agree to provide straightforward access for high-risk patients, while working with healthcare professionals to define best practices. In a post-hoc analysis of this group, Praluent was associated with a lower risk of death from any cause by 29%.

There were no new safety signals in the trial.

A potent, expensive cholesterol drug sold by Regeneron Pharmaceuticals and Sanofi significantly reduced major adverse heart events in a huge study presented on Saturday but it remains to be seen whether the new data will prompt insurers to pay for increased use of the medicine.

"Sanofi and Regeneron have launched a new initiative that will expand access to their drug Praluent in the United States". "We will begin working with payers to ensure that high-risk patients have appropriate access".

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ODYSSEY OUTCOMES (N = 18,924) assessed the effect of alirocumab on the occurrence of MACE in patients who had experienced an ACS between 1-12 months (median, 2.6 months) before enrolling in the trial, and who were already on maximally-tolerated statins.

Odyssey followed patients on average for 3.3 years and the risk reduction versus placebo was increasing over time.

The intention is to take a precision medicine approach to addressing the burden of cardiovascular disease, by focusing efforts on high-risk patients most vulnerable for future CV events, such as those who have suffered a previous event and are unable to reduce their LDL cholesterol (LDL-C) below 100 mg/dL despite statin therapy. Approximately 90% of patients were on a high-intensity statin.

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.

Praluent functions by preventing the binding of proprotein convertase subtilisin/kexin type 9 (PCSK9) to the LDL receptor.

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.