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Sanofi and Regeneron presented Odyssey outcomes data for Praluent at ACC 2018 on Saturday Sanofi and Regeneron presented Odyssey outcomes data for Praluent at ACC 2018 on Saturday
Anna Jefferson | 12 March, 2018, 22:15

Sanofi and Regeneron have scored a major victory in their fight with Amgen in the market for cardiovascular drugs, after releasing data showing their Praluent injection reduces risk of cardiovascular events in high-risk patients, and was associated with a lower death rate.

Regeneron/Sanofi heart drug succeeds in major trial; Will insurers pay?

The companies followed the data with an announcement to cut the price of Praluent (alirocumab) for the high-risk patients who need it the most - a one-two combination aimed at knocking down Amgen and its rival, Repatha (evolocumab).

In keeping with ICER's established "in confidence" procedures, Sanofi and Regeneron provided early access to data from the Odyssey Outcomes trial to ICER, an independent organization that evaluates the value of prescription drugs and other health care innovations, to enable a revised assessment of alirocumab value incorporating the Odyssey Outcomes results.

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.

In an unusual step aimed at reversing the drug's commercial woes, Sanofi and Regeneron signaled willingness to reduce the net price of Praluent for certain high-risk patients if USA payers agree to ease restrictions that have so far limited access to the drug.

"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.

Praluent reduced the overall risk of MACE - which includes heart attack, ischemic stroke, death from coronary heart disease (CHD), or unstable angina requiring hospitalisation - by 15 percent, and was also linked with a lower death risk of death overall, the firms noted. Approximately 90% of patients were on a high-intensity statin.

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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.

Results were presented at the American College of Cardiology's 67th Annual Scientific Session in Orlando.

"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".

"The results were not trivial", said Fuster, from Mount Sinai Hospital in NY.

"It may take years and years to really reap all the benefits that one can achieve", study co-chairman Dr. Gregory Schwartz said.

The trial was created to maintain patients' LDL-C levels between 25-50 mg/dL, using two different doses of Praluent (75 mg and 150 mg). It is unclear if benefits would have been more pronounced had more patients received the higher dose.

Since then, however, both treatments have struggled to find a commercial footing, hamstrung by access restrictions put in place by insurers unwilling to pay for the expensive drugs - both of which carry list prices of more than $14,000 a year.

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