FDA Accepts Pfizer's Biologics License Application For Investigational Meningococcal B Vaccine
Pfizer announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for bivalent recombinant LP2086 (rLP2086), the company’s 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.
“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 Dr. Emilio Emini, senior vice president of Vaccine Research and Development 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 U.S. adolescents.”