LONDON (dpa-AFX) - GlaxoSmithKline plc (GSK, GSK.L) said it has submitted a Marketing Authorisation Application or MAA to the European Medicines Agency, seeking approval for its candidate shingles vaccine, Shingrix, for the prevention of herpes zoster or 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 regulatory submission for the candidate vaccine is based on a comprehensive phase III clinical trial program 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 phase III clinical trial program showed that by reducing the incidence of shingles, the candidate vaccine also reduced the overall incidence of postherpetic neuralgia or PHN, a form of chronic pain associated with shingles.
GlaxoSmithKline is seeking EU regulatory approval for the vaccine to be given intramuscularly in two doses, with a two-to-six month interval between doses.
The submission to the EMA follows regulatory submissions to the U.S. Food and Drug Administration or FDA in October of this year, and to Canada regulatory authorities earlier this month, with a Japan submission planned for 2017.
Copyright RTT News/dpa-AFX
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