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.
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