LP2086 filed with the FDA for Meningococcal Disease-Pfizer
Pfizer has submitted a Biologics License Application (BLA) to the FDA 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 to 25 year olds. The submission is backed by clinical data from a Phase II study published in the Lancet Infectious Diseases in 2012 which showed 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 III studies.
Additionally, in two Phase II 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.
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