Sanofi and Regeneron say that regulators in Europe have agreed to review their closely-watched cholesterol drug alirocumab, which they intend to market as Praluent.
The submission to the European Medicines Agency for Praluent as a treatment for hypercholesterolemia contains data from more than 5,000 patients, including 10 Phase III trials. It was filed with the US Food and Drug Administration in the fourth quarter.
The drug inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), which reduces the liver's ability to remove low-density lipoprotein or ‘bad’ cholesterol from the blood. At the end of last week, Sanofi and Regeneron presented positive topline data from the first two Phase III trials to assess alirocumab administered every four weeks.
There is much interest in the PCSK9 class and Praluent will go up against Amgen’s evolocumab. The latter has an FDA Prescription Drug User Fee Act target action date of August 27 and Amgen is also suing Sanofi and Regeneron for patent infringement.