Pfizer Inc. announced today 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.

“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.

For more details, go to: http://www.pfizer.com/news/press-release/press-release-detail/pfizer_announces_submission_of_biologics_license_application_to_the_fda_for_investigational_meningococcal_b_vaccine