Health Canada approves Novartis' Menveo for prevention of meningococcal disease

- Menveo licensed in 11 to 55 year olds to help protect against potentially deadly meningitis and sepsis caused by four common vaccine-preventable serogroups - Meningococcal disease causes approximately 50,000 deaths globally each year, many of which could be prevented through vaccines - Novartis plans to seek licensure of Menveo in infants and children two to 10 years of age

Novartis Pharmaceutical Canada Inc. announced that Menveo (Meningococcal (Groups A, C, Y and W-135) Oligosaccharide CRM197 Conjugate Vaccine), a quadrivalent meningococcal conjugate vaccine was approved by Health Canada for active immunization of adolescents (11 to 18 years of age) and adults (19 to 55 years of age) to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135.

"Meningococcal disease is particularly distressing because it can rapidly kill or debilitate previously healthy adolescents. Even with early and appropriate treatments, patients can die from meningococcal disease, often within 24 to 48 hours of onset of symptoms. This is why we welcome this new vaccinethat can prevent meningococcal disease caused by all four vaccine-preventable serogroups." says Kathryn Blain, founder and chair of the Meningitis Research Foundation of Canada (www.meningitis.ca).

"Menveo is a welcome addition to our armamentarium in preventing this deadly disease. In the head-to-head study versus Menactra comparing the rate of protection for both vaccines that studied adolescents and adults. Menveo demonstrated superiority for A, Y and W-135 serotypes. These results are theoretically significant given we know that circulating antibodies are necessary for protection. However, the clinical significance is not yet known" says Jay Keystone, MD, FRCPC, Professor, Department of Medicine, University of Toronto and Senior Staff Physician, Toronto General Hospital.

The National Advisory Committee on Immunization is now recommending that a dose of meningococcal conjugate vaccine be given in early adolescence, ideally around 12 years of age, even if the adolescent was previously vaccinated as part of a routine infant or toddler vaccination program. This adolescent dose is to ensure that circulating antibodies are present as adolescents enter the peak years for invasive meningococcal disease beyond infancy, which are between 15 and 24 years of age.

In Canada, the incidence of meningococcal disease varies, ranging between 200 and 250 cases per year. As many as one in 7 patients who contract meningococcal disease die from it. Approximately one in 5 meningococcal disease survivors suffer serious, permanent and devastating side effects, including limb amputations, seizures, paralysis, hearing loss and learning disabilities. Meningococcal disease is a leading cause of bacterial meningitis, which is an infection of the membrane around the brain and spinal cord, and sepsis, an often life-threatening bloodstream infection.

Approval of Menveo is the result of 10 years of dedicated effort by Novartis Vaccines to provide a vaccine that can help protect people against meningococcal disease. The Menveo development program for other age groups continues in multiple Phase III clinical trials.