GlaxoSmithKline has 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 (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 (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.
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.1,2
GSK senior vice-president and head of vaccines R&D, Dr Emmanuel Hanon, said: “Shingles is a common but serious condition that results from the reactivation of the virus that causes chicken pox and can cause lasting pain and other complications.
“The probability of developing shingles increases with age and it is estimated that up to one in every three people will develop shingles during their life. GSK’s shingles candidate vaccine has consistently shown high efficacy in older people in its phase III development programme. Today’s file submission puts us a step closer to making this vaccine available to help protect more people from shingles and the complications associated with it.”
At 1:53pm: (LON:GSK) GlaxoSmithKline PLC share price was +18.75p at 1541.75p
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