Pfizer Submits BLA for Meningococcal B Vaccine
Pfizer announced the submission of a Biologics License Application (BLA) to the FDA for bivalent recombinant LP2086 (rLP2086), a vaccine candidate for the prevention of invasive meningococcal disease caused by Neisseria meningitides serogroup B in 10–25 year olds.
The meningococcal B vaccine targets LP2086, or factor H binding protein, which is found on the surface of the meningococcal B bacterium. The vaccine contains two recombinant versions of the LP2086 antigen, one representative for each of the two known genetic subfamilies of the antigen.
Clinical data from a Phase 2 study demonstrated that the investigational bivalent rLP2086 vaccine induced bactericidal antibodies in healthy adolescents aged 11–18 years which 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, 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.
For more information call (800) 438-1985 or visit Pfizer.com.