The US Food and Drug Administration will undertake a speedy assessment of Sanofi and Regeneron’s promising cholesterol drug Praluent, with a verdict expected by July 24.
The move means Praluent (alirocumab) could bag a US approval for hypercholesterolaemia before Amgen’s rival evolocumab, which has an FDA Prescription Drug User Fee Act target action date of August 27.
Both drugs belong to the closely-watched PCSK9 inhibitor (proprotein convertase subtilisin/kexin type 9) class, which reduce the liver's ability to remove low-density lipoprotein or ‘bad’ cholesterol from the blood.
But Amgen has filed a lawsuit in the USA against Sanofi and Regeneron claiming that Praluent infringes three of its patents for evolocumab, and is gunning for a total block on sales. Read more on that here.
The submission for Praluent contains data from more than 5,000 patients, including 10 Phase III ODYSSEY trials, which together with additional ongoing studies will include more than 23,500 patients. European regulators are already reviewing the drug.