Pfizer Submits BLA For Bivalent Recombinant LP2086 - Quick Facts

(RTTNews) - Drugmaker Pfizer Inc. (PFE) said it has submitted a Biologics License Application or BLA to the U.S. Food and Drug Administration for bivalent recombinant LP2086 or 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, around 500,000 cases of meningococcal disease occur worldwide due to N. meningitidis. The majority of invasive meningococcal disease cases globally 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, about 40 percent of cases in the U.S. were due to meningococcal disease caused by serogroup B.

Despite the availability of antibiotic treatment, between 10 and 15 percent of patients with meningococcal disease die and 11 to 19 percent of those who survive are afflicted with long-term disabilities, like brain damage, hearing loss, learning disabilities or limb amputations. There is currently no meningococcal B vaccine approved for use in the U.S.

The FDA has a 60-day filing review period to determine whether the BLA is complete and acceptable for filing.