GlaxoSmithKline b meningitis vaccine recognized by FDA breakthrough therapy

Source: GSK announced today that its b-meningitis vaccine bexsero has been approved by the U.S FDA as a breakthrough therapy (BTD) to prevent invasive meningococcal disease (IMD) caused by serotype B meningococci in children aged 2-10 In 2014, bexsero was recognized by the FDA as a breakthrough therapy for the prevention of IMD in people aged 10-25 years, and obtained accelerated approval in January 2015 Today's new identification is the second breakthrough treatment identification of bexsero, which also makes bexsero the first vaccine in the world to obtain two breakthrough treatment identification Meningococcal B infection is the leading cause of fatal meningitis Although not common, IMD develops rapidly and affects children and adolescents who are usually healthy Because the initial symptoms of IMD are similar to influenza, it increases the difficulty of diagnosis and leads to high mortality Even with proper treatment, about one in ten patients will die In addition, up to 20% of bacterial meningitis patients may have major physical or neurological disabilities Dr Rino Rappuoli, chief scientist of GlaxoSmithKline vaccine, has spent more than 20 years developing bexsero He said: "this breakthrough therapy recognition emphasizes the importance of solving major scientific challenges such as IMD, and shows the breakthrough in disease prevention through reverse vaccine development and other methods GlaxoSmithKline is committed to the pursuit of innovative vaccines to help prevent serious diseases " Dr Thomas Breuer, chief medical officer of GlaxoSmithKline vaccine, said: "35% of all meningitis B cases in the United States occur in children under the age of 11 Therefore, this identification is an important step in the prevention of meningitis, making the vaccine possible for susceptible age groups We look forward to continuing to work with regulators and public health partners to provide this vaccine to this vulnerable population " We congratulate GlaxoSmithKline on this progress and look forward to the early use of vaccines to protect children from encephalitis