Sanofi and Regeneron to expand U.S. access to Praluent

Endpoints News

Endpoints News

Sell-side analysts comment on Regeneron Pharmaceuticals (REGN +0.7%) and Sanofi's (SNY +0.5%) announced price reduction on cholesterol med Praluent (alirocumab).

Results from the trial were presented during a late-breaker session at the American College of Cardiology's (ACC) 67 Annual Scientific Session in Orlando on Saturday.

The drug, which is injected every two weeks or every four weeks based on strength, allows the liver to remove more LDL from the blood and lowers the concentration of LDL cholesterol in the blood.

Insurers have balked at paying for Praluent and a rival Amgen drug, which dramatically lower "bad" LDL cholesterol but carry list prices of more than $14,000 a year before discounts, over fear of the cost of use over many years by millions of patients.

Alirocumab is a fully human monoclonal antibody that works by blocking PCSK9.

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"It's the ultimate outcome; it's what matters to patients", said study leader Dr. Philippe Gabriel Steg of Hospital Bichat in Paris.

The ODYSSEY OUTCOMES data, backed with a public commitment to work with payers to reduce prices in patients who stand to benefit the most, is the ideal riposte to Amgen.

Researchers enrolled almost 19,000 patients at more than 1,300 centers in 57 countries to test Praluent.

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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. Patients were tracked for at least two years, including 44 percent who were tracked for three years or more.

Efforts will be focused on patients who are most vulnerable for future cardiovascular events, such as those who have suffered a previous coronary event and are unable to reduce their cholesterol below a healthy level despite maximally-tolerated statin therapy.

Praluent-treated patients started the trial on 75 mg every 2 weeks, and 2,615 of them switched to 150 mg every 2 weeks because their LDL-C levels remained above 50 mg/dL.

In a pre-specified analysis, the patients with baseline LDL cholesterol (LDL-C) levels at or above 100 mg/dL experienced a more pronounced effect from alirocumab, reducing their risk of MACE by 24% (HR=0.76, CI: 0.65-0.87), and in a post-hoc analysis of the same group, the drug was associated with a lower risk of death from any cause by 29% (HR=0.71, CI: 0.56-0.90).

On the primary endpoint, Praluent reduced the overall risk of MACE by 15%. It cleared blocked arteries by 15 percent.

Dr. Valentin Fuster, who critiqued the trial at the meeting but was not involved in the study, said the data show that what is considered normal LDL today may be too high. "I hope this particular study really is a trigger for making this drug much more available to people who need it". A price of $4,500 to $8,000 per year would be justified for patients with LDL over 100, the group said.

While Amgen has data showing Repatha can reduce heart attacks and strokes by 20% in at-risk patient when added to statin therapy, it has produced no evidence of a reduction in mortality rates. "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".

"The hard data from the Odyssey Outcomes trial confirms ... that treatment with Praluent does lead to a reduction of both cardiovascular and all-cause deaths, particularly for the higher-risk patient population", said David Whitrap, a spokesman for ICER, which conducted the review.

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