Novartis Receives Complete Response Letter From FDA For Menveo
Published: 30-Jun-2009
FDA has requested additional information on clinical and CMC sections of BLA
Novartis Vaccines and Diagnostics (Novartis) has received feedback from FDA in the form of an initial regulatory determination. Feedback was for the Biologics License Application (BLA) for the investigational vaccine, Menveo.
FDA has requested additional information on the clinical and the CMC (Chemistry Manufacturing and Control) sections of BLA. No new clinical trials are required, and it is expected that Novartis will be able to respond to all questions fully in 2009. The BLA was submitted on August 28 for use of Menveo in subjects aged 11 - 55.
In clinical trials, Menveo has shown to elicit a protective immune response against four of the most common serogroups - A, C, W-135 and Y - of Neisseria meningitides, also known as meningococcus, claims the company.
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