The FDA designates GlaxoSmithKline's (NYSE:GSK) meningitis B vaccine Bexsero [Meningococcal group B Vaccine (rDNA, component, adsorbed)] a Breakthrough Therapy for the prevention of invasive meningococcal disease in children ages 2 -10.
Bexsero in currently approved in the U.S. for people aged 10 - 25.
The company says 35% of meningitis B cases in the US occur in children under 11 years old.
Breakthrough Therapy status provides for more intensive guidance from the FDA on development, the involvement of more senior agency personnel and a rolling review of the marketing application.
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