Pfizer announced that the FDA has accepted for review its Biologics License Application (BLA) for bivalent recombinant LP2086 (rLP2086), a vaccine candidate for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in 10–25 year olds.
The investigational meningococcal B vaccine is composed of two recombinant LP2086 antigens, or factor H binding proteins (fHBP). Antigens from both types of fHBP, subfamily A and subfamily B have been included in the vaccine.
Clinical data from a Phase 2 study showed the investigational bivalent rLP2086 vaccine induced bactericidal antibodies in healthy adolescents aged 11–18 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.
Previously in March 2014, the FDA granted Breakthrough Therapy designation for bivalent rLP2086. 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.
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