Novartis announced that Menveo (Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine), a quadrivalent meningococcal conjugate vaccine was approved by the US Food and Drug Administration (FDA) for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 in people 11 to 55 years of age.

Meningococcal disease infects more than 500,000 people each year, leading to more than 50,000 deaths globally. As many as 1 in 7 patients who contract meningococcal disease die from it. Approximately 1 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. Even with early and appropriate treatment, the disease may progress rapidly and is potentially fatal, often within 24-48 hours of onset of symptoms.

"The FDA approval of Menveo is an important milestone for adolescent immunization in the United States. According to CDC estimates, approximately 16 million adolescents between the ages of 11 and 18 are at risk and remain unprotected against meningococcal disease," said Andrin Oswald, Division Head of Novartis Vaccines and Diagnostics. "Meningococcal disease is particularly distressing because it can rapidly kill or debilitate previously healthy adolescents. For this reason, we are dedicated to helping eradicate meningococcal disease in the United States and around the world."

In the United States, incidence of meningococcal disease varies, ranging between 1,000 and 3,000 cases per year.

FDA approval of Menveo was based on a phase III head-to-head clinical trial that compared Menveo to the other US-licensed ACWY meningococcal conjugate vaccine among subjects 11 to 55 years of age. The trial, which was broken into two subsets - adolescents, age 11 to 18, and adults, age 19 to 55 - measured for each of the four serogroups both the percentage of subjects who achieved an immune response as measured by seroresponse and proportions achieving human serum bactericidal antibody (hSBA) titers >=1:8. Additionally the study examined antibody level as measured by geometric mean titers (GMT).

"Even with early and appropriate treatment, patients can die from meningococcal disease, often within 24-48 hours of onset of symptoms. Menveo achieved a higher immune response than the other currently available vaccine, which is very reassuring," said Keith S. Reisinger, MD, Medical Director, Primary Physicians Research, Inc., Pittsburgh, Penn. "With the FDA approval of Menveo, now healthcare providers in the United States have another option to help prevent this life-threatening invasive disease."

In study participants aged 11 to 18 years, Menveo met its primary endpoint for all four serogroups using hSBA seroresponse. The percentages of subjects who demonstrated an immune response (i.e., achieved an hSBA titer >=1:8) for each serogroup for Menveo and its comparator (the other currently US-licensed ACWY meningococcal conjugate vaccine) respectively, were: Serogroup A - 75: 67; serogroup C - 84: 84; serogroup Y - 88: 69; and serogroup W-135 - 96: 88.

The seroresponse with Menveo for serogroups A, Y and W-135, was statistically higher. However the clinical relevance of higher post-vaccination immune responses is not known.

In the same group, the levels of circulating antibodies (i.e., GMT) in those who received Menveo vs. those who received the comparator, respectively, were: Serogroup A - 29: 18; serogroup C - 59: 47; serogroup Y - 51: 18; and serogroup W-135 - 87: 44.

Since 2005, the Advisory Committee on Immunization Practices, a group of 15 experts who advise the US Centers for Disease Control and Prevention (CDC) on the control of vaccine-preventable diseases, has recommended routine immunization with a quadrivalent meningococcal conjugate vaccine for all adolescents, 11 to 18 years of age, college freshmen living in dormitories and people in other high risk groups who are 19 to 55 years of age.

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 programme for other age groups continues in multiple phase III clinical trials. Menveo has the potential to be utilized in a broad age range, and the company plans to seek supplementary licensures for use of the vaccine in other age groups. Data to support an indication for children 2 to 10 years of age is expected to be submitted in the first half of 2010. Novartis expects to file data to support an infant indication in 2011.