New breakthrough designation continues Bexsero's brilliant run

7 February 2018

GlaxoSmithKline’s (LSE: GSK) Bexsero (meningococcal group B vaccine (recombinant, adsorbed)) has become the first vaccine in the world to receive the Breakthrough Therapy designation from the US Food and Drug Administration (FDA) twice.

The vaccine has now received this designation in the prevention of invasive meningococcal disease (IMD) caused by serogroup B in children aged two to 10 years of age, having previously done so in 2014 in the prevention of IMD in individuals from 10 to 25 years of age.

In the latter indication, it was granted accelerated approval in the USA in January 2015, and it is now licensed in more than 35 countries and has become key to the strong performance of GSK’s meningitis vaccines in major markets in the last couple of years. To date, the UK drugmaker has distributed more than 20 million doses of Bexsero worldwide.

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