Breakthrough Therapy Designation for Meningococcal B Vaccine Candidate
Share this article:
facebook
twitter
linkedin
google
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.