Pfizer Inc. announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (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.
Each year, approximately 500,000 cases of meningococcal disease occur worldwide due to N. meningitidis. The majority of invasive meningococcal disease cases worldwide can be attributed to five N. meningitidis serogroups (A, B, C, W-135 and Y). Disease caused by N. meningitidis serogroup B has been estimated at between 20,000 and 80,000 cases per year globally. In 2012, approximately 40% of cases in the United States were due to meningococcal disease caused by serogroup B. Despite the availability of antibiotic treatment, between 10 and 15% of patients with meningococcal disease die and 11 to 19% of those who survive are afflicted with long-term disabilities, such as brain damage, hearing loss, learning disabilities or limb amputations. There is currently no meningococcal B vaccine approved for use in the United States.
“The BLA submission for bivalent rLP2086 marks an important step toward our goal of helping to protect adolescents and young adults against this difficult to diagnose and often deadly disease,” said Dr. Emilio Emini, senior vice president of Vaccine Research and Development for Pfizer Inc. “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.”
The FDA has a 60-day filing review period to determine whether the BLA is complete and acceptable for filing. Pfizer will communicate the agency’s decision.
Pfizer’s investigational meningococcal B vaccine targets LP2086, or factor H binding protein, which is found on the surface of the meningococcal B bacterium. The gene for factor H binding protein is present in more than 1,800 meningococcal B isolates studied by Pfizer researchers. The vaccine contains two recombinant versions of the LP2086 antigen, one representative for each of the two known genetic subfamilies of the antigen.
Date: June 17, 2014