FDA Approves Pfizer’s Meningitis Vaccine Trumenba

The FDA approved under its breakthrough therapy designation pathway Pfizer’s meningitis vaccine Trumenba, the first vaccine to prevent a deadly strain of meningococcal disease.

The vaccine will prevent a strain of meningococcal disease caused by Neisseria meningitidis serogroup B in patients ages 10-25. Before Trumenba, there were only vaccines that prevented four out of five main serogroups of N. meningitidis bacteria: A, C, Y and W, the FDA said.

The approval was based on three randomized studies in the U.S. and Europe involving rouhgly 2,800 adolescents. “Among study participants who received three doses of Trumenba, after vaccination, 82 percent had antibodies in their blood that killed four different N. meningitidis serogroup B strains compared with less than 1 percent before vaccination,” the agency said.

The agency assessed the safety of the vaccine in roughly 4,500 individuals in studies conducted in the U.S., Europe and Australia.

The drug became only the 14th product to be approved under the FDA’s breakthrough therapy program. FDA officials have said they want to hold a public meeting to help drugmakers understand the criteria for submitting a breakthrough therapy designation request, noting that many applications are incomplete or not appropriate for the pathway.

The drug will be manufactured by Pfizer’s subsidiary Wyeth. — Robert King

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.