GSK: meningitis vaccine wins fast-track FDA designation

(CercleFinance.com) - GlaxoSmithKline's Bexsero has received "breakthrough therapy designation" from the US FDA for the prevention of a life-threatening meningitis, the British pharmaceutical giant said today.


GSK specified that the Food and Drug Administration's decision relates to its meningitis B vaccine Bexsero for the prevention of invasive meningococcal disease (IMD) caused by serogroup B in children of 2-10 years old.

In 2014 Bexsero already received "breakthrough therapy designation" for development in the prevention of invasive meningococcal disease in patients of 10-25 years of age, before being approved in early 2015.

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