The BLA is backed by data from a phase III clinical trial program, assessing the vaccine’s efficacy, safety and immunogenicity in over 37,000 patients.
The program demonstrated that by reducing the incidence of shingles, Shingrix also reduced the overall incidence of postherpetic neuralgia (PHN), a form of chronic pain related with 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.
GSK senior vice president and head of vaccines R&D Emmanuel Hanon said: “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.”
Apart from the US, GSK plans to file for Shingrix regulatory submissions in the European Union and Canada in 2016. The company is also planning to seek approval in Japan in 2017.
Shingrix is a non-live, recombinant vaccine to help avoid herpes zoster and its complications. It combines glycoprotein E, a protein identified on the varicella zoster virus that causes shingles, with an adjuvant system, AS01B, which aims to improve the immunological response to the antigen.
A clinical trial is also underway to assess revaccination in subjects who have earlier been vaccinated against shingles with the existing available live-attenuated vaccine.
Further studies are underway in solid and haematological cancer patients, haematopoietic stem cell and renal transplant recipients and HIV-infected people.
Image: GlaxoSmithKline, Center City, Philadelphia. Photo: courtesy of Beyond My Ken.