Alirocumab is an investigational monoclonal antibody targeting proprotein convertase subtilisin/kexin type 9 (PCSK9).
The marketing application is based on data from more than 5,000 patients, including ten Phase III ODYSSEY trials.
Along with additional ongoing trials including ODYSSEY OUTCOMES, the ODYSSEY clinical trial program will include over 23,500 patients at more than 2,000 study centers in double-blind, randomized, placebo-and active-controlled trials ranging from 24 weeks to about five years.
In the fourth quarter of 2014, the companies also submitted a biologics license application (BLA) for Praluent to the US Food and Drug Administration (FDA).
Both EMA and FDA have conditionally accepted Praluent as the trade name for alirocumab.
Currently, the safety and efficacy of alirocumab have not been fully evaluated by any regulatory authority.
Earlier, the companies have reported positive results from two new Phase III ODYSSEY trials, which evaluated alirocumab that was administered every four weeks to patients with hypercholesterolemia.
Both the trials, which met their primary efficacy endpoints, compared the reduction from baseline in low-density lipoprotein cholesterol (LDL-C) at 24 weeks with alirocumab versus placebo in these patients.