Pfizer's meningococcal B vaccine BLA accepted; gains priority review

The US Food and Drug Administration has accepted for review the Biologics License Application for bivalent recombinant LP2086 (rLP2086), pharma giant Pfizer’s (NYSE: PFE) vaccine candidate for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in 10 through 25 year olds.

The FDA has also granted Priority Review designation for the BLA, providing an anticipated Prescription Drug User Fee Act (PDUFA) action date of February 14, 2015. The  FDA granted Breakthrough Therapy designation for bivalent rLP2086 earlier this year based, in part, on data from clinical trials studying the safety and immunogenicity of bivalent rLP2086.

“Pfizer has closely collaborated with the FDA since 2008 to develop our meningococcal B vaccine candidate with the intent to help prevent this devastating disease,” said Emilio Emini, senior vice president of vaccine R&D for Pfizer. “Both the acceptance of Pfizer’s Biologics License Application today, and its Priority Review designation, are significant regulatory milestones that underscore the importance of our efforts to expedite the approval and subsequent availability of our meningococcal B vaccine for US adolescents,” Dr Emini added.