GlaxoSmithKline receives European approval for hepatitis B vaccine
GlaxoSmithKline (GSK) has received European approval for marketing Fendrix, its hepatitis B vaccine formulated with AS04, which contains MPL from Corixa.
GlaxoSmithKline (GSK) has received European approval for marketing Fendrix, its hepatitis B vaccine formulated with AS04, which contains MPL from Corixa.
A combination of GSK Biologicals' hepatitis B antigen and a novel GSK proprietary adjuvant system, AS04, Fendrix was developed to have a higher potency than other available hepatitis vaccines, resulting in higher, more rapid and longer-lasting seroprotection It prevents hepatitis B in patients with renal insufficiency, including specific high-risk groups such as pre-haemodialysis and haemodialysis patients from 15 years of age onwards, where the immune response is typically lower than in healthy individuals.
AS04 is a component of a highly promising HPV vaccine against cervical cancer that recently showed 100% efficacy against persistent infection with HPV types 16 and 18. MPL is a component of GSK Bio's malaria vaccine, which also recently reported breakthrough results in clinical trials in the field, and a component of its genital herpes vaccine, which showed excellent efficacy against genital herpes in women in a phase III trial published in 2002.