Posted by Michael Wonder on 26 Nov 2016
GSK announces EU regulatory submission of candidate vaccine for prevention of shingles - follows regulatory submissions in US and Canada
25 November 2016 - GlaxoSmithKline today announced the regulatory submission of a marketing authorisation application to the EMA seeking approval for its candidate shingles vaccine, Shingrix, 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 post-herpetic 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.
