Novartis Vaccines and Diagnostics received feedback from the US Food and Drug Administration (FDA) in the form of an initial regulatory determination on the Biologics License Application (BLA) for the investigational vaccine Menveo.
The FDA has requested additional information on the clinical and the CMC (Chemistry Manufacturing and Control) sections of the 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, 2008 for use of Menveo in subjects age 11 to 55.
In clinical trials, Menveo has been 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. These serogroups can cause potentially deadly bacterial infections and account for most cases of meningococcal disease worldwide.
"Meningococcal disease is a devastating illness that can result in rapid death or have long-lasting repercussions for survivors and their families," said Andrin Oswald, CEO of Novartis Vaccines and Diagnostics. "We are dedicated to applying our industry-leading technology and expertise to further the development of Menveo and other vaccines that elicit robust, long-lasting, protective immune responses for all age groups at risk."
Menveo is based on the same proprietary technology Novartis Vaccines pioneered to produce Menjugate, a meningococcal serogroup C conjugate vaccine approved outside the US since 2000 for use in individuals from age two months through adulthood.