GSK files BLA at FDA for Shingrix, a vaccine to prevent herpes zoster (shingles).
GlaxoSmithKline announced that it has submitted a Biologics License Application (BLA) for its candidate shingles vaccine, Shingrix, to the 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.
See- "Efficacy of an Adjuvanted Herpes Zoster Subunit Vaccine in Older Adults" Himal Lal et al. NEJM April 28, 2015 DOI:10.1056/NEJMoa1501184
Cunningham et al., N Engl J Med 2016; 375: 1019-32. "Efficacy of the herpes zoster subunit vaccine in adults 70 years of age or older"-
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