GlaxoSmithKline has submitted a Biologics License Application (BLA) for its candidate shingles vaccine, ShingrixTM, to the United States Food and Drug Administration (FDA).
As the company has further explained in its Monday press release, this approval is 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. As said in the company’s PR, 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, GSK has said.
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. 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.”