Sanofi, Regeneron to submit PCSK9 application for priority review

Regeneron Pharmaceuticals, Inc. and Sanofi announced that they plan to use an FDA rare pediatric disease priority review voucher to submit a Biologics Licensing Application for alirocumab.

Alirocumab is an investigational, monoclonal antibody-targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) drug that is intended to lower LDL-C in patients who are having trouble meeting LDL-C target levels using standard therapies.

A press release said that Regeneron Ireland, a subsidiary of Regeneron Pharmaceuticals, purchased the priority review voucher from BioMarin GALNS Ltd., a subsidiary of BioMarin Pharmaceutical, Inc. The voucher was originally granted through the Rare Pediatric Disease Priority Review Voucher Program from the FDA.

A priority review voucher allows for a Biologics Licensing Application to be expedited through a 6-month review process. The standard review duration is 10-months. A company can apply for a new voucher through the FDA’s Office of Orphan Products Development; however, Sanofi and Regeneron split the acquisitioned voucher’s cost of $67.5 million, the press release said.

“The priority review voucher program was established to provide incentives that would enhance innovation in key areas of unmet patient need,” Ned Braunstein, MD, vice president of regulatory affairs at Regeneron, said in a press release from the company. “Our decision to acquire and leverage the voucher is clear evidence that this program is a valuable incentive for biopharmaceutical companies.”

For more information, see the press release from Regeneron Pharmaceuticals, Inc and the FDA’s Rare Pediatric Disease Priority Review Voucher Program.