Posted by Michael Wonder on 08 Feb 2018
GSK’s meningitis B vaccine Bexsero receives breakthrough therapy designation from US FDA for prevention of invasive meningococcal disease in children 2-10 years of age
7 February 2018 - GlaxoSmithKline today announced that it has received breakthrough therapy designation from the U.S. FDA for its meningitis B vaccine Bexsero [meningococcal group B Vaccine (rDNA, component, adsorbed)] for the development of the vaccine in the prevention of invasive meningococcal disease caused by serogroup B in children 2-10 years of age.
Bexsero is the first vaccine in the world to receive the breakthrough therapy designation twice. In 2014, Bexsero received breakthrough therapy designation 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.
