GSK submits biologics licence application to FDA for shingles vaccine

24 October 2016 (Last Updated October 24th, 2016 18:30)

GlaxoSmithKline (GSK) has submitted a biologics licence application to the US Food and Drug Administration (FDA) for approval of its candidate shingles vaccine, Shingrix, to help prevent herpes zoster (shingles) in people aged 50 years or more.

GlaxoSmithKline (GSK) has submitted a biologics licence application to the US Food and Drug Administration (FDA) for approval of its candidate shingles vaccine, Shingrix, to help prevent herpes zoster (shingles) in people aged 50 years or more.

The drug candidate is not currently approved for use anywhere in the world and is a non-live, recombinant vaccine developed to help prevent shingles and associated complications.

Shingrix combines glycoprotein E, a protein found on the varicella zoster virus (VZV) that causes shingles, with an adjuvant system, AS01B, which is intended to improve the immunological response to the antigen3.

GSK vaccines head and senior vice-president Dr Emmanuel Hanon 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.

"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 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.”

During a Phase III clinical trial programme, the candidate vaccine was found to reduce the overall incidence of postherpetic neuralgia (PHN), a form of chronic pain associated with shingles, by reducing the incidence of shingles.

GSK is seeking regulatory approval for the vaccine to be given intramuscularly in two doses, with a two to six-month interval between doses.

The company has plans to file for approval of the drug in Europe and Canada by the end of this year, and Japan by 2017.