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Trumenba, the first vaccine authorized in the United States to prevent meningococcal disease caused by Neisseria meningitidis serogroup B, has been approved by the Food and Drug Administration, the agency announced Oct. 29. The vaccine is approved for use in individuals aged 10-25 years.
Trumenba was approved in less than 6 months through the FDA’s accelerated approval program after recent outbreaks of serogroup B infection on U.S. college campuses, including Princeton University and the University of California, Santa Barbara, raised concerns about the urgent need for prevention, Dr. Karen Midthun, director of FDA’s Center for Biologics Evaluation and Research, said in a media briefing.
Trumenba was used in response to both outbreaks under special FDA permission that allows for investigational agents to be administered in urgent circumstances. Before its approval in the United States, the vaccine was licensed for use in Europe, Canada, and Australia.
Until now, meningitis vaccines available in the U.S. were meningococcal polysaccharide vaccine (Menomune) and meningococcal conjugate vaccine (Menactra, Menveo and MenHibrix), which only protect against four of the five disease serogroups: A, C, Y, and W, according to the Centers for Disease Control and Prevention.
Out of approximately 500 cases of meningococcal disease in 2012, 160 were caused by serogroup B, said Dr. Midthun.
Three studies to evaluate Trumenba’s efficacy were conducted in about 2,800 adolescents in the United States and Europe, the FDA said. Of participants who received three doses of the vaccine, 82% had antibodies that eliminated four different serogroup B strains, compared with less than 1% before receiving Trumenba.
Trumenba is manufactured by Wyeth Pharmaceuticals. For important safety information, please visit their website.
Trumenba, the first vaccine authorized in the United States to prevent meningococcal disease caused by Neisseria meningitidis serogroup B, has been approved by the Food and Drug Administration, the agency announced Oct. 29. The vaccine is approved for use in individuals aged 10-25 years.
Trumenba was approved in less than 6 months through the FDA’s accelerated approval program after recent outbreaks of serogroup B infection on U.S. college campuses, including Princeton University and the University of California, Santa Barbara, raised concerns about the urgent need for prevention, Dr. Karen Midthun, director of FDA’s Center for Biologics Evaluation and Research, said in a media briefing.
Trumenba was used in response to both outbreaks under special FDA permission that allows for investigational agents to be administered in urgent circumstances. Before its approval in the United States, the vaccine was licensed for use in Europe, Canada, and Australia.
Until now, meningitis vaccines available in the U.S. were meningococcal polysaccharide vaccine (Menomune) and meningococcal conjugate vaccine (Menactra, Menveo and MenHibrix), which only protect against four of the five disease serogroups: A, C, Y, and W, according to the Centers for Disease Control and Prevention.
Out of approximately 500 cases of meningococcal disease in 2012, 160 were caused by serogroup B, said Dr. Midthun.
Three studies to evaluate Trumenba’s efficacy were conducted in about 2,800 adolescents in the United States and Europe, the FDA said. Of participants who received three doses of the vaccine, 82% had antibodies that eliminated four different serogroup B strains, compared with less than 1% before receiving Trumenba.
Trumenba is manufactured by Wyeth Pharmaceuticals. For important safety information, please visit their website.
Trumenba, the first vaccine authorized in the United States to prevent meningococcal disease caused by Neisseria meningitidis serogroup B, has been approved by the Food and Drug Administration, the agency announced Oct. 29. The vaccine is approved for use in individuals aged 10-25 years.
Trumenba was approved in less than 6 months through the FDA’s accelerated approval program after recent outbreaks of serogroup B infection on U.S. college campuses, including Princeton University and the University of California, Santa Barbara, raised concerns about the urgent need for prevention, Dr. Karen Midthun, director of FDA’s Center for Biologics Evaluation and Research, said in a media briefing.
Trumenba was used in response to both outbreaks under special FDA permission that allows for investigational agents to be administered in urgent circumstances. Before its approval in the United States, the vaccine was licensed for use in Europe, Canada, and Australia.
Until now, meningitis vaccines available in the U.S. were meningococcal polysaccharide vaccine (Menomune) and meningococcal conjugate vaccine (Menactra, Menveo and MenHibrix), which only protect against four of the five disease serogroups: A, C, Y, and W, according to the Centers for Disease Control and Prevention.
Out of approximately 500 cases of meningococcal disease in 2012, 160 were caused by serogroup B, said Dr. Midthun.
Three studies to evaluate Trumenba’s efficacy were conducted in about 2,800 adolescents in the United States and Europe, the FDA said. Of participants who received three doses of the vaccine, 82% had antibodies that eliminated four different serogroup B strains, compared with less than 1% before receiving Trumenba.
Trumenba is manufactured by Wyeth Pharmaceuticals. For important safety information, please visit their website.
FROM AN FDA MEDIA BRIEFING
