| 2016-11-25 10:29:58|
GSK 10:29 11/25 11/25/16
GlaxoSmithKline announces EU regulatory submission for shingles vaccine
GlaxoSmithKline announced the regulatory submission of a Marketing Authorisation Application to the European Medicines Agency seeking approval for its candidate shingles vaccine, Shingrix, for the prevention of herpes zoster 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. The regulatory submission for the candidate vaccine is based on a comprehensive phase III clinical trial programme evaluating its efficacy, safety and immunogenicity in more than 37,000 people. This includes the ZOE-50 and ZOE-70 studies published in the New England Journal of Medicine in April 2015 and September 2016, respectively. The submission to the EMA follows regulatory submissions to the U.S. FDA in October of this year and to Canada regulatory authorities earlier this month, with a Japan submission planned for 2017.