Sanofi and Regeneron posts positive Praluent cholesterol data

Sanofi and Regeneron were able to update its PCSK9 therapy Praluent with the positive data showing it could reduce levels of ‘bad’ cholesterol in patients with type 2 diabetes. The patients in the trial were at high risk of cardiovascular problems and it is a positive indication before the outcome of the companies’ trial into whether the drug could improve CV problems.

In the meantime, before the ODYSSEY OUTCOME trial results emerge later this year, the companies have two trials that back up that Praluent is both safe and effective when used alongside insulin. In the two studies, the drug was able to hit the primary endpoints of significantly reducing low-density lipoprotein cholesterol (LDL-C) and was superior to standard care in reducing non-high-density lipoprotein (non-HDL-C).

The studies found a 48.2% reduction from baseline in LDL-C with the use of Praluent in patients, against a 0.8% reduction by placebo. In non-HDL cholesterol, there was a 37.3% reduction against 4.7% in standard care.

"Patients with long-standing diabetes, including insulin-treated patients, are at high risk of cardiovascular disease," said Lawrence Leiter, chair of the ODYSSEY DM Steering Committee and Director of the Lipid Clinic at the Li Ka Shing Knowledge Institute at St. Michael's Hospital, University of Toronto, Canada. "The positive results from ODYSSEY DM-INSULIN provide valuable information on the efficacy and safety of Praluent in this high cardiovascular risk group."

As Leitar notes, the positive results in diabetes patients with CV risk, particularly with the reduction of non-HDL cholesterol (an indicator of CV risk), could be significant when it comes to later data from the ODYSSEY OUTCOME trial. Amgen has already released its data from Praluent-rival Repatha, but was not able to display a clear-cut reduction in cardiac death risk. Sanofi and Regeneron will be hoping to do one better in their own results that will be posted late in 2017 or early 2018.