- Pfizer's Trumenba is the first FDA-approved vaccine for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B. This is also the first biologic with a breakthrough therapy designation to be approved by the FDA.
- Approval was based on clinical data showing Trumenba-related immune response to the four most prevalent strains of meningoccocal serogroup B strains in the U.S.
- The Center for Biologics Evaluation and Research (CBER) worked closely with Pfizer to facilitate rapid approval; however, approval is contingent upon ongoing studies to test Trumenba against other serogroup B strains.
Out of a total of seven biolgics that have been granted Breakthrough Therapy status by the CBER, Trumenba is the first to be approved. The recent outbreak of serougroup meningoccocal B disease on college campuses has made it clear that there is an unmet medical need.
The clinical studies for Trumenba, which began in November 2012 and and are still being conducted, are well-designed and rigorous, with a total of more than 20,000 participants. Trumenba is administered to people between the ages of 10 and 25 in a series of three doses over a six-month period. This regimen has proven to be effective at fostering robust immunity against meningoccocal serogroup B bacterial infection.
But Pfizer has some competition. Novartis' Bexsero is going after the same indication and has also been granted breakthrough designation status by the FDA. With an extensive submission file, including more than 15,000 subjects, Bexsero has a good chance of being approved. It is already licensed and in use in Europe, Australia, and Canada.