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Regeneron/Sanofi heart drug succeeds in major trial

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

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.

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. "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". 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. This appears to be the main driver behind their plan to discount the medication for high-risk patients. He argues it's a "no brainer" more patients should be on the Sanofi and Regeneron drug than now are.

"We were really pleased to see the treatment was effective and associated with a reduction in mortality".

Odyssey tested Praluent in almost 19,000 patients who experienced an acute coronary event the year before their enrollment. It is unclear if benefits would have been more pronounced had more patients received the higher dose. Doctors say this finding, though not statistically clear-cut (more on that below), could still drive greater adoption of the expensive cholesterol drug.

Investigators followed the patients for an average of 33 months. Amgen - which has been locked in litigation with Sanofi and Regeneron over PCSK9 patent rights - reported positive cardiovascular outcomes data for its drug a year ago when it published the results of the FOURIER trial.

Complications in the highest-risk group Praluent Patients Placebo Patients Heart attack, stroke, hospitalization, death 11.5% 14.9% Death from any cause 4.1% 5.7%. It's important to note that a comparison between the two trials isn't apples to apples due to differences in design and patient base.

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Regeneron and Sanofi's move to adopt ICER's recommended price range reflects the growing scrutiny of drug costs, and calls for pharmaceutical companies to price their products according to their value to patients, rather than what the market will bear, ICER President Steven D. Pearson said in an interview.

In December, Repatha won an FDA label saying it can reduce the risk of cardiovascular events, becoming the first PCSK9 drug boasting the indication.

Meanwhile, the drugmakers are locked in a patent dispute that could make the discussion moot.

While Amgen and Sanofi and Regeneron battle it out with the PCSK9s, another competitor could be lurking in Esperion.

The exact discount that insurers receive will depend on how much they relax restrictions on who gets the drug, Dr. Schleifer said. If the drugs were used more broadly to treat all patients included in the trial, the cost-effective price would be in a range of $2,300 to $3,400 annually, ICER said.

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