January 26, 2015
Regeneron And Sanofi Announce Praluent™ (Alirocumab) Biologics License Application Has Been Accepted For Priority Review By FDA
Regeneron Pharmaceuticals, Inc. and Sanofi announced today that the U.S. Food and Drug Administration has placed the Biologics License Application for cholesterol drug Praluent under priority review. The drug, which is also known as alirocumab, is a monoclonal antibody designed to target PCSK9 for the treatment of hypercholesterolemia.
The goal of the priority review is six months with a target action date of July 24, 2015. The BLA contains more than 5,000 patients, including results from 10 Phase III ODYSSEY trials. In addition to ongoing studies, the ODYSSEY clinical trial program is set to include more than 23,500 patients at approximately 2,000 study centers.
The Release of Clinical Study Data
Back in March 2014, Regeneron and Sanofi announced that they would present data from alirocumab clinical studies at the American College of Cardiology’s 63rd Annual Scientific Session. The goal was to exhibit progress made on the drug, designed to combat hypercholesterolemia.
“Despite the availability of lipid-lowering therapies, millions of people worldwide are unable to satisfactorily control their levels of low-density lipoprotein-cholesterol,” said George Yancopoulos, chief scientific officer and president of Regeneron.
Some of the data that was shown examined the safety and efficacy of the drug in patients over the course of 52 weeks. Research also showed the impact of alirocumab in patients who took 150mg every two weeks, in addition to the effects of the drug in patients who were not receiving statin.
At the time, the data positioned the companies to propose its BLA to the FDA for priority review. It was eventually sent it to the FDA in the fourth quarter of 2014.
Acceptance from the EMA
At the beginning of 2015, Sanofi and Regeneron Pharmaceuticals, Inc. announced that the European Medicines Agency had accepted the Marketing Authorization Application for Praluent. The MAA contained data from more than 5,000 patients.
Both the MAA and FDA had accepted Praluent as the trade name for alirocumab. No regulatory authority had examined the drug for safety and efficacy up to this point.
Regeneron focuses on manufacturing medicines for the treatment of various medical conditions. Some of its most common targets are eye diseases, colorectal cancer and hypercholesterolemia. Sanofi’s research encompasses a wide range of focuses including diabetes solutions, human vaccines and consumer healthcare.
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