Research & Development
US Food and Drug Administration grants breakthrough therapy designation for GlaxoSmithKline's Bexsero
9 February 2018 -

The US Food and Drug Administration has granted breakthrough therapy designation for United Kingdom-based GlaxoSmithKline's meningitis B vaccine, Bexsero [Meningococcal group B Vaccine (rDNA, component, adsorbed)], it was reported yesterday.

The approval is intended for the development of the vaccine in the prevention of Invasive Meningococcal Disease caused by serogroup B in children 2-10 years of age. It is the first vaccine in the world to receive the Breakthrough Therapy Designation twice.

GSK Vaccines chief scientist, Rino Rappuoli, said, 'This designation emphasises the importance of tackling big scientific challenges like meningitis B and breaking new ground in disease prevention through approaches like reverse vaccinology. GSK is committed to the pursuit of innovative vaccines that help protect against serious diseases with significant unmet need.'

Bexsero is licensed in more than 35 countries.

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