Pfizer announced that the FDA has granted Breakthrough Therapy Designation for bivalent rLP2086, an investigational vaccine for the prevention of invasive meningococcal disease due to Neisseria meningitides serogroup B in patients 10–25 years old.
This investigational meningococcal B vaccine targets LP2086, or factor H-binding protein, which is found on the surface of the meningococcal B bacterium.
The Breakthrough Therapy Designation is based on data from 2 clinical trials assessing the safety and immunogenicity of rLP2086. Clinical data from a Phase 2 study showed the rLP2086 vaccine induced bactericidal antibodies in healthy adolescents (11–18 years old) that were broadly active against meningococcal B bacteria. Another Phase 2, randomized, placebo-controlled, single-blind study of two- and three-dose schedules of rLP2086 in healthy adolescents (11–18 years old), showed that the investigational vaccine had an acceptable safety profile.
A clinical development program is underway for rLP2086, including Phase 2 and Phase 3 trials evaluating over 20,000 patients. Pfizer intends to submit a Biologics License Application (BLA) by mid-2014.
For more information call (800) 438-1985 or visit Pfizer.com.