Novartis files Bexsero at FDA for Meningococcal Disease
Novartis has announced the submission of a Biologic License Application (BLA) to the 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.
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