Pfizer Inc. 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.”
Pfizer’s investigational meningococcal B vaccine is composed of two recombinant LP2086 antigens, or factor H binding proteins (fHBP). The 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.
Pfizer is conducting a global clinical development program for bivalent rLP2086, which includes both Phase 2 and Phase 3 trials evaluating more than 20,000 participants, approximately 14,000 of whom will receive the investigational vaccine. The Phase 3 program began in November 2012 with the initiation of a large scale safety study. Additional immunogenicity and safety studies are also ongoing.
The FDA granted Breakthrough Therapy designation for bivalent rLP2086 in March 2014 based, in part, on data from clinical trials studying the safety and immunogenicity of bivalent rLP2086.
Clinical data from a Phase 2 study published in the Lancet Infectious Diseases in 2012 showed the investigational bivalent rLP2086 vaccine induced bactericidal antibodies in healthy adolescents aged 11 to 18 years that were broadly active against meningococcal B bacteria. Safety data from the study also showed the vaccine had an acceptable safety profile in this healthy adolescent study population and supported the further evaluation of the vaccine in Phase 3 studies.
Additionally, in two Phase 2 studies presented at the Annual Meeting of the European Society for Paediatric Diseases (ESPID) in May 2014, bivalent rLP2086 was found to elicit bactericidal responses against diverse meningococcal serogroup B test strains.
Date: August 14, 2014