GSK submits shingles vaccine for US regulatory approval

(ShareCast News) - Pharmaceutical behemoth GlaxoSmithKline announced it has submitted a shingles vaccine for a US regulatory approval. Shingrix, a non-live recombinant vaccine, which prevents herpes zoster, or shingles, in people aged 50 years or over, was submitted to the US Food and Drug Administration for approval for the vaccine to be given intramuscularly in two doses with a two to six month interval.In the second phase of a clinical trial the vaccine also showed it reduced the overall incidence of chronic pain associated with shingles.In addition to the FDA, the company is on track for regulatory submissions to the European Union and Canada this year and for Japan in 2017.Dr Emmanuel Hanon, senior vice president and head of vaccines research and development, 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."The FDA regulatory submission was based a phase three clinical trial on its efficacy, safety and immunogenicity in over 37,000 people, which includes the ZOE-50 and ZOE-70 studies published in the New England Journal of Medicine in April 2015 and September respectively.