GlaxoSmithKline announced this week that it has submitted a Biologics License Application (BLA) for its candidate shingles vaccine, ShingrixTM, to the United States Food and Drug Administration (FDA), seeking approval 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.
Dr Emmanuel Hanon, Senior Vice President and Head of Vaccines R&D, GSK said: “Shingles is a common and potentially serious condition. It can cause lasting pain and other complications such as scarring or visual impairment, which can severely impact the quality of people’s lives. The risk of developing shingles increases with age and it is estimated that up to one in every three people is at risk. The 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.”
The regulatory submission for Shingrix is based on a comprehensive phase III clinical trial programme evaluating its efficacy, safety and immunogenicity in more than 37,000 people.