Published: Tue, March 13, 2018
Medicine | By Douglas Stevenson

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

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

Patients receiving Praluent also experienced a statistically valid reduction in the overall risk of death (hazard ratio = 0.85) versus control.

Alongside the data the companies announced plans to boost the affordability and accessibility of Praluent for patients most in need, by offering a reduced net price to USA payers that agree to reduce "burdensome access barriers" for high-risk patients.

"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.

Image: The Odyssey Outcomes trial, which evaluated Praluent, met its primary endpoint. 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.

While fewer heart-related deaths with Praluent did not reach statistical significance, there was a nominally significant reduction in all-cause deaths - 334 versus 392 for placebo, researchers reported.

The findings described Saturday at the American College of Cardiology conference in Orlando, Florida, were based on an global trial of almost 19,000 people randomly assigned to either alirocumab or a placebo. 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.

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". In the long-term trail patients on high-dose statin therapy had been randomised 1:1 for Pradulent combination and statin monotherapy and were treated for an average (median) of 2.8 years.

Some cardiologists believe much longer studies are needed to discover the true value of these drugs.

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

Patients with higher baseline LDL-C levels (at or above 100 mg/dL) experienced a more pronounced effect from the drug, which reduced the risk of MACE by 24 percent, and cut the risk of death from any cause by 29 percent. There was no difference in neurocognitive events (1.5% Praluent; 1.8% placebo) or new-onset diabetes (9.6% Praluent; 10.1% placebo).

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