Novartis announced today the submission of a Biologic License Application (BLA) to the US Food and Drug Administration (FDA) for marketing approval for the use of Bexsero (Multicomponent Meningococcal Group B Vaccine [recombinant, adsorbed]) to help protect against invasive meningococcal disease caused by serogroup B (meningitis B) in adolescents and young adults from 10 years through 25 years of age. This submission initiates a rolling submission process for Bexsero to the FDA, following the receipt of a Breakthrough Therapy designation in April.

Bexsero is the first broad coverage vaccine to help protect against meningitis B. The vaccine is already approved in 34 countries including across the European Union, Canada and Australia. Since the launch of Bexsero in 2013, over half a million doses have been distributed worldwide.

For more details, go to: http://www.novartis.com/newsroom/media-releases/en/2014/1793710.shtml