Cholesterol drug from Sanofi/Regeneron gains US CV risk reduction use

Sanofi and Regeneron’s Praluent cholesterol drug has been approved in the US to help prevent cardiovascular events, a new indication that will help it compete with Amgen’s rival from the same class, Repatha.

Both drugs are from the PCSK9 inhibitor class and have been duking it out in the US market since they were approved to help people with inherited high cholesterol after unsuccessful statin therapy, within a few weeks of each other in the summer of 2015.

They have got off to a slow start since their simultaneous launch and have failed to bring in the sales expected - Praluent's sales were 79 million euros in Q4 (around $88 million), while Repatha’s total was $159 million.

However they may begin to gain traction now that they both have FDA backing for use to prevent heart attacks, and Sanofi is claiming an advantage with data showing that its drug showed a “meaningful reduction” in death from any cause in a large cardiovascular outcomes trial.

Amgen’s drug was the first to get approval to prevent heart attacks, strokes and coronary revascularisations in adults with established cardiovascular disease at the end of 2017, and Sanofi has now caught up with this new indication.

Sanofi and Regeneron can add a similar indication to Praluent’s label, after it was approved to reduce risk of heart attack, stroke and unstable angina requiring hospital in adults with established cardiovascular disease to its label.

FDA approval was based on data from the ODYSSEY OUTCOMES trial, published in November last year, assessing the effect of adding Praluent to maximally-tolerated statins on CV outcomes in 18,924 patients who had an acute coronary syndrome (ACS) within a year of enrolling in the trial.

Results showed a statistically significant 15% reduced risk for major cardiovascular events.

This was broken down into a non-significant 27% reduced risk of stroke, 14% risk of non-fatal heart attack and 39% reduced risk of unstable angina requiring hospitalisation.

There was also a non-significant 15% reduced risk of death from all-cause mortality.

John Reed

John Reed, global head of R&D at Sanofi, said: “Praluent has already helped many adults lower their LDL-C levels, and this new indication provides an opportunity to help appropriate patients by reducing the risk of serious, life-threatening cardiovascular events, including heart attacks and stroke.”