[Menveo is a quadrivalent vaccine for bacterial meningitis, an illness that (unlike viral meningitis) is often life-threatening—even when promptly treated with antibiotics. The FDA has not requested any new clinical trials and NVS expects to file a response before year-end.]
Cambridge, MA, June 30, 2009 - 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 - 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."
About the Novartis Vaccines global meningococcal franchise
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 2 months through adulthood.
Studies have reported that Menveo generates a robust immune response against the four vaccine-preventable serogroups, A, C, W-135 and Y in people across age groups from infancy to adulthood. A Phase II study in infants published in the January 9, 2008, issue of the Journal of the American Medical Association reported that Menveo is the first meningococcal vaccine candidate to elicit a robust immune response in infants. There is no vaccine currently licensed in the US for use in infants.
Novartis Vaccines is a global leader in providing vaccines to protect against deadly meningococcal disease. Through industry-leading scientific expertise, the company is focused on extending critical meningococcal vaccines research. In addition to Menveo, Novartis Vaccines is developing a recombinant vaccine for its potential to provide broad coverage against multiple strains of serogroup B, for which no vaccine is currently available. The company has already distributed more than 26 million doses of Menjugate around the world and produced MenZB®, a vaccine against a strain of meningococcus B specific to a recent outbreak in New Zealand.
About meningococcal disease, a leading cause of bacterial meningitis
Meningococcal disease can manifest as bacterial meningitis - an infection of the protective coverings of the brain and spinal cord - or meningococcemia - a bloodstream infection. It is caused by the bacterium Neisseria meningitidis (N. meningitidis). The symptoms, which can include sudden onset of fever, rash, headache and stiff neck, can progress rapidly. Even with early and appropriate treatment, between 10% and 14% of meningitis cases are fatal, typically within 24 to 48 hours. For those who survive, as many as 19% suffer serious long-term consequences such as deafness, neurological damage or limb loss.
Because invasive meningococcal disease can progress so rapidly, high levels of circulating antibodies are critical for protection. Immune memory typically takes up to five days to develop, so there often is not enough time for immune memory to mount a protective response.
Five serogroups cause the majority of meningococcal disease worldwide: A, B, C, W-135 and Y. Distribution of serogroups varies widely from geographic region to region and changes over time. In the US, the prevalence of serogroup Y has increased over the last few years (from 9% of reported cases in 1990-92 to 39% in 2006). Serogroups B and C are predominant in Europe. While Asia has primarily seen serogroup A, recent outbreaks of serogroup C have been noted. The dynamic and unpredictable nature of meningococcal disease epidemiology warrants a vaccine that offers broad serogroup protection. For more information, please visit www.meningitis.com.‹
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