Cholesterol drug significantly reduced patients' risk of death in trial

It’s the first time a cholesterol-lowering drug has reduced deaths since statins such as Lipitor and Crestor came out decades ago

The discount deal would apply only to patients with dangerously high levels of cholesterol who are at especially high risk for heart attack or stroke.

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. Such patients face a substantial risk of further cardiovascular problems and related death, particularly if their cholesterol level is not adequately controlled.

Regeneron is accelerating and improving the traditional drug development process through its proprietary VelociSuite technologies, including VelocImmune to yield optimized fully-human antibodies, and ambitious initiatives such as the Regeneron Genetics Center, one of the largest genetics sequencing efforts in the world. This action of the drug allows the liver to remove more LDL from the blood and lowers the concentration of LDL cholesterol in the blood. That price would be tied to an independent review of Praluent's value based on the new risk reduction data from the multi-year study called Odyssey Outcomes. It's the first study with a PCSK9 inhibitor to show an associated mortality benefit, researchers said.

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.

Sanofi and Regeneron Pharmaceuticals, Inc.recently announced that the ODYSSEY OUTCOMES trial met its primary endpoint, showing Praluent (alirocumab) significantly reduced the risk of major adverse cardiovascular events (MACE) in patients who had suffered a recent acute coronary syndrome (ACS) event such as a heart attack. "I hope this particular study really is a trigger for making this drug much more available to people who need it".

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The analyses described above include the results from 730 patients (8%) in the Praluent group who continued to be assessed in the Praluent arm despite stopping active Praluent therapy, as specified in the protocol for patients with persistent LDL-C readings below 15 mg/dL. Months can go by before a patient gets them.

The trial was created to maintain patients' LDL-C levels between 25-50 mg/dL, using two different doses of Praluent (75 mg and 150 mg).

Patients were randomly assigned to receive injections of either alirocumab or placebo every two weeks. Insurers have placed significant restrictions on paying for Praluent because of its price, such as requiring patients to have tried alternative treatments and having doctors submit voluminous paperwork proving their patients need the drug. If LDL cholesterol levels dropped consistently below 15 mg/dL, the patient was switched to placebo, again in a blinded fashion. Overall, the primary endpoint occurred in 9.5 percent of those receiving alirocumab and 11.1 percent of those receiving placebo, while 3.5 percent of those receiving alirocumab and 4.1 percent of those receiving placebo died.

Praluent's impact on the actual number of deaths from coronary heart disease was modest, however, failing to reach statistical significance (p=0.38). However, Steg noted there may not have been enough events in each subcategory to show a definite difference. Importantly, no significant safety signals were seen across the study of nearly 19,000 patients. Insurers often balk at their high list prices, some $14,000 apiece per patient, per year.

Investor Relations Conference Call on ODYSSEY OUTCOMES Sanofi and Regeneron will be hosting a conference call for the financial community on ODYSSEY OUTCOMES. Follow @ACCinTouch, @ACCMediaCenter and #ACC18 for the latest news from the meeting. The ACC leads in the formation of health policy, standards and guidelines.

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