Cholesterol drug significantly reduced patients' risk of death in trial

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Sanofi and Regeneron have pledged to make Praluent more accessible to patients as data show that the drug significantly cut the risk of cardiovascular events in high-risk patients.

In the study, it was observed that alirocumab significantly reduced the risk of major adverse cardiovascular events (MACE) in patients who had suffered a recent acute coronary syndrome (ACS) event, like a heart attack. The two companies immediately announced that they were willing to offer price breaks on the costly medication.

The drug, Praluent, also led to fewer deaths among high-risk patients, which could be the strongest argument for insurers to finally remove barriers that have severely constrained sales and frustrated physicians trying to get the medicine to patients.

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.

The findings described Saturday at the American College of Cardiology conference in Orlando, Florida, were based on an worldwide trial of almost 19,000 people randomly assigned to either alirocumab or a placebo. The group found that a net price of $4,500 to $8,000 per year would be cost-effective if the drugs were used only by the subgroup of patients whose risk of death was reduced by 29%.

These analyses include the results from 730 patients (8%) in the alirocumab group who continued to be assessed in the alirocumab arm despite stopping active alirocumab therapy, as specified in the protocol for patients with persistent LDL-C readings below 15 mg/dL. 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.

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. Last October, a judge tossed a ban on Sanofi and Regeneron's Praluent sales, setting up a new trial between the rivals.

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"Inventing innovative medicines only matters if the people who need these products are able to access them - and that is unfortunately not the case with Praluent today", said Leonard Schleifer, president and chief executive of Regeneron.

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

The companies will meet with U.S. 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.

Patients receiving Praluent also experienced a statistically valid reduction in the overall risk of death (hazard ratio = 0.85) versus control. The participants were on the highest statin dose they could tolerate and received either placebo or Praluent in addition to their statin therapy. It's important to note that a comparison between the two trials isn't apples to apples due to differences in design and patient base.

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

Regeneron and Sanofi's offer of a steep price cut reflects the intensifying pricing pressures that some drugmakers face.

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