Regeneron And Sanofi Say Test Shows Praluent Lowers Risk Of Death

Leslie Hanson
March 12, 2018

"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".

"I think that will impress the field and people who have to make (reimbursement) decisions", said Dr. Phillippe Steg, the study's co-chairman who presented the data at the American College of Cardiology meeting in Orlando, Florida.

Praluent was shown to have cut down the overall risk of major adverse cardiovascular events (MACE) by 15%, which is the primary endpoint of the trial. "We are prepared to improve access and affordability, eliminating burdensome barriers for high-risk patients in need", said Olivier Brandicourt, MD, chief executive officer of Sanofi.

There were no new safety signals in the trial.

Sanofi has announced the launch of a new access to medicines initiative with Regeneron that will help to expand access to their drug Praluent in the US.

"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 trial evaluated the effect of Praluent on the occurrence of MACE in patients who had suffered an ACS event 1-12 months before enrolling in the study, and who were already subjected to maximally-tolerated statins. 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.

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

In a subgroup analysis of highest-risk patients - those with "bad" LDL cholesterol of 100 or above despite maximum statin therapy - Praluent significantly reduced all-cause death risk by 29 percent and risk of the adverse event composite by 24 percent. Alirocumab -treated patients started the trial on 75 mg every two weeks, and switched to 150 mg every two weeks if their LDL-C levels remained above 50 mg/dL (n = 2,615).

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

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