GlaxoSmithKline has filed Biologics License Application in the US for Shingrix, seeking approval to market the vaccine for the prevention of herpes zoster (shingles) in people aged 50 years or over.
Shingrix is a non-live, recombinant vaccine to help prevent shingles and its complications, given intramuscularly in two shots, with a two to six month interval between doses.
GSK says Phase III data - based on more than 37,000 patients - show that by reducing the incidence of shingles the vaccine also cut the overall incidence of postherpetic neuralgia (PHN), a form of chronic pain associated with the condition.
Other complications of shingles include ophthalmologic, neurological and cutaneous disease, which can result in severe disability.
"The risk of developing shingles increases with age and it is estimated that up to one in every three people is at risk," noted Dr Emmanuel Hanon, head of vaccines R&D at GSK. Filing Shingrix "puts us a step closer to making this vaccine available to help protect more people from shingles and the complications associated with it."
Regulatory submissions in the European Union and Canada are on track for 2016 and planned for Japan in 2017.