FDA grants accelerated approval for Bexsero vaccine for prevention of Meningococcal Disease- Novartis

Novartis has announced that the 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 the only meningitis B vaccine approved in the USA 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 Phase II and Phase III studies, Bexsero demonstrated a protective immune response in adolescents and young adults after two doses. Bexsero also offers a flexible dosing schedule, with the first and second doses administered at least one month apart.

In January 2013, Bexsero was approved by the European Commission for use in individuals from 2 months of age and older, making it the first broad coverage vaccine to receive a regulatory approval to help protect against meningitis B.

Comment: Bexsero is the second vaccine approved by the FDA in the past three months from January 2015, to prevent this disease. The agency approved the first meningococcal serogroup B vaccine being Trumenba from Pfizer, in October 2014. Before these approvals, existing approved meningococcal vaccines in the USA covered only four of the five main serogroups of N. meningitidis bacteria that cause meningococcal disease: A, C, Y and W.