GlaxoSmithKline plc has submitted a Biologics License Application (BLA) for its candidate shingles vaccine, Shingrix, to the United States Food and Drug Administration (FDA), seeking approval 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. 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.
The regulatory submission for Shingrix is based on a comprehensive phase III clinical trial programme evaluating its efficacy, safety and immunogenicity in more than 37,000 people. This includes the ZOE-50 and ZOE-70 studies published in the New England Journal of Medicine in April 2015 and September 2016, respectively.
Regulatory submissions in the European Union and Canada are on track for 2016 and planned for Japan in 2017. GSK’s shingles candidate vaccine is not currently approved for use anywhere in the world.
According to an article in CNBC, Shingrix is reportedly among the company's most promising experimental products, since it has shown greater protection among older recipients than Merck's rival shot Zostavax.
GlaxoSmithKline plc has submitted a Biologics License Application (BLA) for
its candidate shingles vaccine, Shingrix, to the United States Food and Drug
Administration (FDA), seeking approval 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. 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.
The regulatory submission for Shingrix is based on a comprehensive phase III
clinical trial programme evaluating its efficacy, safety and immunogenicity in
more than 37,000 people. This includes the ZOE-50 and ZOE-70 studies published
in the New England Journal of Medicine in April 2015 and September 2016,
respectively.
Regulatory submissions in the European Union and Canada are on track for 2016
and planned for Japan in 2017. GSK’s shingles candidate vaccine is not
currently approved for use anywhere in the world.