NEW YORK CITY (dpa-AFX) - Pfizer Inc. (PFE) said Wednesday that the U.S. Food and Drug Administration has granted accelerated approval of TRUMENBA for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.
Approval of TRUMENBA is based on demonstration of immune response, as measured by serum bactericidal activity against four serogroup B strains representative of prevalent strains in the United States. The effectiveness of TRUMENBA against diverse serogroup B strains has not been confirmed.
As part of the accelerated approval process, Pfizer will complete its ongoing studies to confirm the effectiveness of TRUMENBA against diverse serogroup B strains.
TRUMENBA was reviewed and approved under the FDA's Breakthrough Therapy designation and Priority Review programs.
TRUMENBA is to be administered as a 3-dose series at months 0, 2 and 6 in the 10 through 25 year old age group.
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