GlaxoSmithKline (GSK) has obtained breakthrough therapy designation from the US Food and Drug Administration (FDA) for its Bexsero vaccine to prevent invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroup B in children aged between two and ten.
With statistics indicating that around one in ten infected with IMD B die even after treatment, the disease is considered as life-threatening.
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The FDA designation will allow GSK to expedite the development and review of the vaccine, which initially received the breakthrough tag in 2014 for the prevention of IMD in people aged ten to 25.
Bexsero is currently licensed in more than 35 markets, including the European Union, European Economic Area, Australia, Argentina, Chile and Uruguay, where it is indicated for patients aged two months and older.
In the US, the vaccine is approved for individuals from ten to 25 years of age, in Canada for use in people aged two months to 17 years and in Brazil for those aged from two months to 50 years.
GSK Vaccines chief medical officer Dr Thomas Breuer said: “35% of all meningitis B cases in the US occur in children under 11 years old.
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By GlobalData“This designation is an important step forward in meningococcal prevention and extending the protection provided by this vaccine to a vulnerable age group in the US.
“We look forward to continuing to work with regulators and public health partners to make this vaccine available for them.”
