Posted by Michael Wonder on 24 Oct 2016
GSK announces US regulatory submission of candidate vaccine for prevention of shingles
24 October 2016 - Regulatory submissions in the EU and Canada remain on track for 2016.
GlaxoSmithKline today announced that it has submitted a biologics license application for its candidate shingles vaccine, Shingrix, to the US FDA, seeking approval for the prevention of herpes zoster (shingles) in people aged 50 years or over.
The candidate vaccine is a non-live, recombinant vaccine to help prevent shingles and its complications. The phase III clinical trial programme showed that by reducing the incidence of shingles, the candidate vaccine also reduced the overall incidence of postherpetic neuralgia, a form of chronic pain associated with shingles.
Regulatory approval is being sought for the vaccine to be given intramuscularly in two doses, with a two to six month interval between doses.
