Novartis reported FDA clearance for its meningococcal vaccine Menveo® (groups A, C, Y, and W-135). Approval in the U.S. covers use of the quadrivalent conjugate vaccine as active immunization against the development of invasive meningococcal disease caused by relevant Neisseria meningitides serogroups in people aged 11–55 years.
The firm also plans to file for approval of Menveo in younger children later this year, while the submission of data supporting an infant indication is expected during 2011. Menveo is currently pending final approval in Europe. In December 2009, the EMEA’s Committee for Medicinal Products for Human Use recommended sanctioning the vaccine in the EU.
Menveo is based on the same technology as Novartis’ Menjugate® vaccine, a meningococcal serogroup C conjugate vaccine approved outside the U.S. since 2000. “The approval of Menveo is an important milestone for adolescent immunization in the U.S.,” comments Andrin Oswald, division head of Novartis Vaccines and Diagnostics. “According to CDC estimates, approximately 16 million adolescents between the ages of 11 and 18 are at risk and remain unprotected against meningococcal disease.”
Novartis’ meningitis-prevention pipeline includes its MenB vaccine candidate, which is currently in Phase III development in Europe against B serogroup meningococcal meningitis. The company says regulatory submission for MenB in Europe is on track for later this year. Discussions with FDA will determine the scope of Phase III trials in the U.S.