FDA Approves Menveo for Meningococcal Disease

The Food and Drug Administration (FDA) has approved Menveo, a quadrivalent meningococcal conjugate vaccine for individuals 11 to 55 years of age. Manufactured by Novartis Vaccines and Diagnostics, the active immunization prevents invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135. The approval was based on a Phase III clinical trial that showed a higher immune response compared to the other U.S.- licensed ACWY meningococcal vaccine.

Meningococcal disease is a leading cause of bacterial meningitis, an infection of the membrane around the brain and spinal cord, which infects more than 500,000 people each year and leads to more than 50,000 deaths globally. In the U.S., the incidence of meningococcal disease ranges between 1,000 and 3,000 cases per year. Since 2005, the Advisory Committee on Immunization Practices 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.

“The FDA approval of Menveo is an important milestone for adolescent immunization in the U.S.,” says Andrin Oswald, division head of Novartis. “According to CDC estimates, approximately 16 million adolescents between the ages of 11 and 18 are at risk and remain unprotected against meningococcal disease.”

The Menveo development program for other age groups continues in multiple Phase III clinical trials. Data to support an indication for children ages 2 through 10 is expected to be submitted in the first half of 2010, and Novartis expects to file data to support an infant indication in 2011.