GSK submits shingles vaccine candidate for EU approval

26 November 2016

A Marketing Authorization Application (MAA) to the European Medicines Agency, seeking approval for its candidate shingles vaccine, Shingrix, for the prevention of herpes zoster (shingles) in people aged 50 years or over, has been submitted by UK pharma major GlaxoSmithKline (LSE: GSK).

The candidate vaccine is a non-live, recombinant vaccine to help prevent shingles and its complications. 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 (PHN), 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.

Viewed as one of GSK’s most promising investigational product

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