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

13 March 2018

New research indicates that alirocumab (Praluent-Regeneron, Sanofi) reduced patients' risk of death by 15% in a major clinical trial. In the patient population with LDL cholesterol above 100 mg/dL, the reduction in all-cause death was an impressive 29%.

Praluent is part of a relatively new class of drugs called PCSK9 inhibitors which can dramatically lower cholesterol, and may work even better than statins, the traditional first line of treatment. The MACE composite endpoint includes patients who experienced a heart attack, ischemic stroke, death from coronary heart disease (CHD), or unstable angina requiring hospitalization.

"We're not just talking about preventing nonfatal events such as heart attacks but actually preserving life". At the American College of Cardiology meeting, where the data was presented, 62% of the doctors surveyed stated they would change their prescribing habits because of the data.

There were no new safety signals in the trial.

"Many patients who have survived a recent heart attack or other coronary event are unable to reach an LDL cholesterol goal of less than 100 mg/dL, and have an urgent need for new therapeutic options due to their increased risk of another event".

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Regeneron and Sanofi said on Saturday they would lower the net price of Praluent if onerous barriers to its access are removed for the highest-risk patients.

"Sanofi and Regeneron have launched a new initiative that will expand access to their drug Praluent in the U.S.". This appears to be the main driver behind their plan to discount the medication for high-risk patients.

Odyssey followed patients on average for 3.3 years and the risk reduction versus placebo was increasing over time. 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.

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). 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 alirocumab therapy for the remainder of the trial.

Sources: Regeneron (study results); March 10, 2018; Regeneron (pricing offer); March 10, 2018; ICER, March 10, 2018.

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