GSK's meningitis B vaccine Bexsero receives breakthrough therapy designation from FDA
Source - SMW
GlaxoSmithKline's meningitis B vaccine Bexsero received breakthrough therapy designation from the US Food and Drug Administration for prevention of invasive meningococcal disease in children two to ten years of age.
Bexsero is the first vaccine in the world to receive the breakthrough therapy designation (BTD) twice. In 2014, Bexsero received BTD for development in the prevention of invasive meningococcal disease in individuals 10-25 years of age and was subsequently granted Accelerated Approval in January 2015.
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 Vaccines Chief Medical Officer Dr Thomas Breuer said: 'Thirty-five percent of all meningitis B cases in the US occur in children under 11 years old.'
'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.'
At 9:24am: (LON:GSK) GlaxoSmithKline PLC share price was +5.8p at 1248.6p