Pfizer has submitted a biologics licence application to the US Food and Drug Administration (FDA) for approval of its vaccine candidate bivalent recombinant LP2086 (rLP2086) to help protect against invasive meningococcal disease caused by Neisseria meningitidis serogroup B in people aged ten to 25.
Pfizer vaccine research and development senior vice-president Dr Emilio Emini said: "There is an urgent public health need to help prevent meningococcal B disease through vaccination, and we will continue to work closely with the FDA in our efforts to advance our vaccine candidate."
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Pfizer’s bivalent rLP2086 contains two recombinant versions of the LP2086 antigen, one representative for each of the two known genetic subfamilies of the antigen.
The company’s investigational meningococcal B vaccine targets LP2086, or factor H binding protein, which is found on the surface of the meningococcal B bacterium.
At present, the company is conducting a clinical development programme for bivalent rLP2086. This programme includes both Phase II and Phase III studies evaluating more than 20,000 participants, with 14,000 of these receiving the investigational vaccine.
In November 2012, the company initiated the Phase III programme. In addition, immunogenicity and safety studies are also ongoing.
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By GlobalDataIn March, the FDA had granted breakthrough therapy designation for bivalent rLP2086 based, in part, on data from clinical trials studying the safety and immunogenicity of the vaccine.
