Days after Amgen filed evolocumab in the USA, Sanofi and Regeneron have been touting the benefits of their PCSK9 inhibitor cholesterol-lowerer alirocumab at the European Cardiology Society meeting in Barcelona.
The companies presented results from four ongoing Phase III trials of alirocumab in people with hypercholesterolemia, all of which met their primary efficacy endpoint. Among the studies was the ongoing 2,341-patient Odyssey Long Term trial, which showed that at 52 weeks, there was a 57% reduction from baseline in low-density lipoprotein or ‘bad’ cholesterol (LDL-C) levels in the alirocumab group as compared to a 4% increase with placebo.
However the most notable results came from a post hoc safety analysis which noted that mong the alirocumab group, 1.4% of patients suffered a major cardiovascular event compared with 3.0% of those on placebo. The benefit needs to be confirmed but it is the first drug in the PCSK9 class, a protein that reduces the liver's ability to remove bad cholesterol from the blood, to show a reduction in cardiovascular risk.
Sanofi and Regeneron are in a race with Amgen’s evolocumab, which was submitted for approval with the US Food and Drug Administration at the end of last week. Alirocumab has not been filed but last month, Sanofi and Regeneron paid $67.5 million to buy a US priority review voucher from BioMarin that can be used for the drug.