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news.The US Food and Drug Administration (FDA) has approved Novartis for active immunization for prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 in individuals 2 to 10 years of age, however, it has also obtained a Refuse To File (RTF) letter from the FDA for its supplemental Biologics License Application (sBLA) for the use of Menveo in infants from 2 to 12 months.
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The FDA approval was supported by the result from a pivotal Phase III trial data which evaluated the safety and immunogenicity of Menveo against each of the four serogroups were compared with those of the other currently US-licensed ACW-135Y meningococcal conjugate vaccine.
Novartis Vaccines and Diagnostics Division head Andrin Oswald said the response from the FDA on their Menveo infant file is disappointing.
"We believe that concerns raised are of procedural nature and plan to resubmit the sBLA within the next few months," Oswald said.
"This will also provide us with an opportunity to supplement the file with additional clinical data that support expanded use of Menveo in infants and toddlers from 2 months to 2 years old."