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

Anti-cholesterol drug Praluent cuts death risk: Study

Sanofi's alirocumab improves cardiovascular event rate over statins

The findings, presented to the American College of Cardiology conference in Orlando, Florida, were based on a trial in 57 countries, where patients were randomly assigned to receive alirocumab or a placebo.

"We were really pleased to see the treatment was effective and associated with a reduction in mortality".

"It's the ultimate outcome; it's what matters to patients", said study leader Dr Philippe Gabriel Steg of Hospital Bichat in Paris. "Because the treatment effect was so much more marked in the patients with the highest LDL cholesterol, we believe that these patients are the optimal candidates for therapy".

Alirocumab reduced this risk by 24 per cent.

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. Patients were tracked for at least two years, including 44 percent who were tracked for three years or more.

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.

The benefit was even greater among those with stubbornly high "bad", or LDL cholesterol, above 100 mg/dL. "Many patients who have survived a recent heart attack or other coronary event are unable to reach an LDL cholesterol goal of less than 100 mg/dL, and have an urgent need for new therapeutic options due to their increased risk of another event".

Praluent reduced the overall risk of MACE - which includes heart attack, ischemic stroke, death from coronary heart disease (CHD), or unstable angina requiring hospitalisation - by 15 percent, and was also linked with a lower death risk of death overall, the firms noted. An Amgen-backed study released yesterday, for instance, found 65 percent of commercially insured and Medicare patients trying to get a PCSK9 blocker were denied access by their health plans in 2016.

"I don't have a single patient on a PCSK9 inhibitor", says Roxana Mehran, director of interventional cardiovascular research and clinical trials at the Icahn School of Medicine at Mount Sinai.

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. 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.

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.

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.

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