Regeneron to Slash Price of Cholesterol Drug After Showing it Saved Lives

Sanofi and Regeneron presented Odyssey outcomes data for Praluent at ACC 2018 on Saturday

Still, analysts and others will be looking to both sets of results to weigh the drugs' benefits.

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. That group saw a 29 percent reduction in death from any cause after taking the drug for two years.

Alirocumab was also associated with a 15 percent reduction in death from any cause, marking the first evidence that this relatively new class of drugs, called PCSK9 inhibitors, may extend lives.

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. It cleared blocked arteries by 15 percent. While there's a benefit for all patients, the investigators honed in on the highest-risk group because of the chance to make a difference for patients, he said. Cardiologists interviewed by Xconomy say the drugs are nearly always rejected upon first request.

Speaking with FiercePharma, principal investigator Dr. Phillippe Gabriel Steg said the benefit in high-risk patients is particularly important, because it fits what "clinicians would want to do in real practice" and will allow the healthcare system to get the most "bang for the buck". Patients give themselves shots of the medicine once or twice a month. "It's so hard, I give up".

Regeneron and Sanofi's Praluent had US sales of $131.4 million previous year; Amgen's Repatha had USA sales of $225 million.

The offer has been made just after the presentation of the large-scale ODYSSEY OUTCOMES at the American College of Cardiology (ACC) meeting in Orlando, which showed that adding PCSK9 inhibitor Praluent (alirocumab) to high-dose statins reduced cardiovascular events and all-cause mortality compared to statins alone. The organization recommended a price range of $4,500 to $8,000 for those high-risk patients likely to gain the most benefit from Praluent therapy.

In conjunction with the data announcement, Sanofi disclosed that it'll incorporate a new cost-effectiveness review by ICER in future payer negotiations as it fights for market share with rival Amgen and its PCSK9 treatment Repatha.

"With almost 90 percent of the patients in this trial on high-intensity statins, the data demonstrate that a precision-medicine approach in the field of cardiovascular disease may further advance how we better treat high-risk patients", added Elias Zerhouni, president, Global R&D, Sanofi. The drugmaker's cholesterol met phase 3 endpoints in results released this week, and CEO Tim Mayleben has previously said the company is planning to charge $9 or $10 per day, which would fall below the low end of the range ICER suggested for Sanofi's Praluent.

"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".



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