FDA Approves Novartis VaccineBy
Novartis reports that the US Food and Drug Administration (FDA) has granted accelerated approval of Bexsero (meningococcal group B vaccine [recombinant, adsorbed]) for active immunization to prevent invasive meningococcal disease caused by serogroup B (also known as meningitis B) in adolescents and young adults from 10 years through 25 years of age. Bexsero is approved in the US with a two-dose regimen and a flexible dosing schedule. As part of the accelerated approval process, Novartis will complete its ongoing studies to confirm the effectiveness of Bexsero against diverse serogroup B strains.
In January 2013, Bexsero was approved by the European Commission for use in individuals from two months of age and older, making it the first broad coverage vaccine to receive a regulatory approval to help protect against meningitis B, according to Novartis. Bexsero is now licensed in 37 countries, including the member states of the European Union, Australia, and Canada for use in individuals from two months of age and older.