Novartis announced Friday that the FDA granted accelerated approval to its vaccine Bexsero to prevent meningococcal disease caused by Neisseria meningitidis serogroup B in individuals aged 10 to 25 years. The company noted that "Bexsero is the only meningitis B vaccine approved in the US with a two-dose regimen and a flexible dosing schedule," adding it will complete ongoing studies to confirm the vaccine's efficacy against various serogroup B strains as part of the expedited approval process.
The US regulator, which granted breakthrough therapy status to Bexsero last April, cited data from three studies involving approximately 2600 adolescents and young adults showing that 62 percent to 88 percent of those who received two doses of the vaccine had achieved protective immune responses to three different Neisseria meningitidis serogroup B strains, compared with 0 percent to 23 percent before vaccination.
Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research, remarked that "with today's approval of Bexsero, the US now has two vaccines for the prevention of serogroup B meningococcal disease," following the clearance of Pfizer's Trumenba (meningococcal group B vaccine) in October last year.
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