The US FDA has also granted priority review status for the BLA with an expected Prescription Drug User Fee Act (PDUFA) action date of 14 February 2015.
Pfizer Vaccine Research and Development senior vice-president Emilio Emini said the company has closely collaborated with the FDA since 2008 to develop its meningococcal B vaccine candidate with the intent to help prevent this devastating disease.
"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," Emini said.
The rLP2086 vaccine is composed of two recombinant LP2086 antigens, or factor H binding proteins (fHBP).
The investigational meningococcal B vaccine includes antigens from both types of fHBP, subfamily A and subfamily B, as our preclinical research has shown that this approach has the potential to provide coverage against the majority of meningococcal B strains.
The company is carrying out a global clinical development program for bivalent rLP2086, which includes both Phase II and Phase II trials assessing over 20,000 participants, about 14,000 of whom will receive the investigational vaccine.