Pfizer Inc. (NYSE: PFE) today announced that Trumenba (Meningococcal Group B Vaccine) received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for active immunization to prevent invasive disease caused by Neisseria meningitidis group B (MenB) in children ages 1 through 9 years. This is the first Breakthrough Therapy designation for a MenB vaccine to help protect children as young as 1 year of age. Trumenba previously received Breakthrough Therapy designation in 2014 for the prevention of MenB in adolescents and young adults ages 10 through 25 years, and later the same year received FDA approval as the first MenB vaccine approved in the U.S.
The October 2014 Approval Letter, required Pfizer to assess the safety and effectiveness of Trumenba in children down to 1 year of age. Pfizer has successfully completed Phase 2 studies in this investigational age group and these data have been submitted to the FDA. These data supported Pfizer’s request for Breakthrough Therapy designation.
The majority of invasive meningococcal disease cases worldwide can be attributed to six Neisseria meningitidisserogroups (A, B, C, W, X, and Y). Together, serogroups A, B, C, W, and Y account for 90% of all invasive meningococcal disease (IMD), with MenB accounting for the majority of disease in adolescents and young adults in the U.S. and Europe. As of 2016, the burden of MenB is highest in adolescents/young adults (32%) and infants (20%), followed by children ages 1 to 4 years (12%) and children ages 5 to 10 years (4%).