The bivalent rLP2086 vaccine is indicated for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in 10 to 25-year-olds.
Pfizer vaccine research and development senior vice president Dr. Emilio Emini said the BLA submission for bivalent rLP2086 marks an important step toward the company’s goal of helping to protect adolescents and young adults against this difficultto diagnose and often deadly disease.
"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," Emini added.
Currently there is no meningococcal B vaccine approved for use in the US, according to the company.
The bivalent rLP2086 is being evaluated through Pfizer’s global clinical development program, which includes both Phase 2 and Phase 3 trials assessing over 20,000 subjects.
During the trials, around 14,000 subjects will be administered the investigational vaccine. The Phase 3 program started in November 2012 with the initiation of a large scale safety study.
Based, in part, on data from clinical trials studying the safety and immunogenicity of bivalent rLP2086, the FDA granted Breakthrough Therapy designation for bivalent rLP2086 in March 2014.
The FDA has a 60-day filing review period to determine whether the BLA is complete and acceptable for filing.