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

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

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.

The net price range is based on a cost-effectiveness analysis by an independent nonprofit group called the Institute for Clinical and Economic Review. The price cut is also notable because the latest clinical data from Regeneron, released today at the American College of Cardiology's yearly meeting, shows that alirocumab not only lowers the risk of heart attacks like Amgen's does, but might also lower the chance of death as well-something the rival drug hasn't been shown to do. REGN 0.27% and Sanofi SA said they will seek to renegotiate their contracts with insurers by offering rebates and discounts for the drug, called Praluent, that would bring its U.S.net price within a range of $4,500 to $8,000 annually per patient, down from its list price of $14,600.

Praluent is yet to be approved by any regulatory agency, when it comes to its use in reducing the risk of MACE. The MACE composite endpoint includes patients who experienced a heart attack, ischemic stroke, death from coronary heart disease (CHD), or unstable angina requiring hospitalization.

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.

"Not all patients with heart disease are the same".

"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 high-risk group is the estimated 1.3 million people in the US 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.

Praluent functions by preventing the binding of proprotein convertase subtilisin/kexin type 9 (PCSK9) to the LDL receptor. As a result, LDL-C levels in the blood are reduced.


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

Regeneron president and chief scientific officer George Yancopoulos said: "This trial was consistent with earlier statin trials, showing the greatest benefit in patients with higher cholesterol levels at baseline". The companies are specifically asking that insurers loosen restrictions only for patients at the highest risk of death-those who have had a heart attack or other serious coronary event in the past year, and whose cholesterol levels exceed the threshold recommended by doctors despite taking statins. This appears to be the main driver behind their plan to discount the medication for high-risk patients.

"Too many patients in urgent need of additional treatment options on top of statins have faced tremendous hurdles to gain access to this important medicine", Sanofi CEO Olivier Brandicourt said in a statement.

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".

"Sanofi and Regeneron have launched a new initiative that will expand access to their drug Praluent in the USA".

For more from the ACC 67 Annual Scientific Session, follow Rare Disease Report on Facebook and Twitter.

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