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

Regeneron CEO Leonard Schleifer shown in 2016 said the exact discount that insurers receive will depend on how much they relax restrictions on who gets the drug

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

The PCSK9 inhibitor, which lowered blood lipids by 40-60% in previous trails, reduced the risk of MACE by 15% and was associated with a 29% lower risk of death overall in a patient population with acute coronary syndrome.

Last year, researchers reported similar results for a different PCSK9 inhibitor called Repatha (evolocumab), made by Amgen Pharmaceuticals, which also cut the risk of heart attack, stroke, and hospitalization for blocked arteries by 15 percent. The study also showed that Praluent caused a reduction in all-cause death.

The news comes as the high price of prescription drugs remains a big political flashpoint; both new U.S. Health and Human Services Secretary Alex Azar and FDA Commissioner Scott Gottlieb amped up the pressure on drug companies, hospitals, and insurers this week to change payment schemes and increase drug price transparency to help drive down healthcare costs. Importantly, no significant safety signals were seen across the study of nearly 19,000 patients.

The drug was deemed extremely safe with no difference from placebo in incidence of neurocognitive problems or new-onset diabetes. 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.

"Not all patients with heart disease are the same". "Through this trial, we have been able to identify high-risk patients treated with optimal statins who still have an urgent need for additional treatment options". Regeneron will now focus its commercial efforts on those patients, and plans to reach out to payers with a deal: provide "straightforward access for high-risk patients", and it will lower the price of alirocumab, according to a press release.




Investor Relations Conference Call on ODYSSEY OUTCOMES Sanofi and Regeneron will be hosting a conference call for the financial community on ODYSSEY OUTCOMES.

Other global numbers available here (https://media.choruscall.ch/documents/Attended_DI_numbers.pdf). ICER today says alirocumab is worth between $4,500 and $8,000 per year for the specific group of "high-risk" patients who benefited the most from treatment in Regeneron's trial-and $2,000 to $3,000 per year for everyone else. Approximately 90% of patients were on a high-intensity statin. Despite their striking ability to lower gobs of LDL-C or "bad" cholesterol, their sales have been meager compared to Wall Street analysts' initial bullish multi-billion dollar projections; alirocumab tallied $194 million a year ago worldwide, evolocumab $319 million. Some patients who switched to 150 mg switched back to 75 mg if their LDL-C fell below 25 mg/dL (n=805), and patients who experienced two consecutive LDL-C measurements below 15 mg/dL while on the 75 mg dose (n=730) stopped active Praluent therapy for the remainder of the trial.

Praluent is yet to be approved by any regulatory agency, when it comes to its use in reducing the risk of MACE.

In the European Union, Praluent was approved for treating adults with primary hypercholesterolemia or mixed dyslipidemia as an adjunct to diet with certain conditions attached. This will allow quick identification of new safety information. The effect of Praluent on cardiovascular morbidity and mortality, however, has not been determined. Founded and led by physician-scientists for 30 years, our unique ability to repeatedly and consistently translate science into medicine has led to six FDA-approved treatments and over a dozen product candidates, all of which were homegrown in our laboratories. All patients had ACS within one month to one year before enrolling in the study.

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