LONDON (Alliance News) - GlaxoSmithKline PLC said on Friday that Shingrix has been approved in Europe and Japan for the prevention of shingles in adults aged 50 and over.
The European Commission has approved Shingrix for the prevention of shingles, also known as herpes zoster, and post-herpetic neuralgia in adults aged 50 years or older.
The Japanese Ministry of Health, Labour and Welfare has also approved Shingrix for the prevention of shingles in adults aged 50 years or older.
Shingrix is a non-live, recombinant subunit adjuvanted vaccine given intramuscularly in two doses.
In Japan, the vaccine is registered to the Japan Vaccine Co Ltd a joint venture of GlaxoSmithKline and Daiichi Sankyo Co Ltd.
Glaxo said Shingrix is the first approved shingles vaccine to combine a non-live antigen, to trigger a targeted immune response, with a specifically designed adjuvant to generate "a strong and sustained immune response".
"The approvals of Shingrix in Europe and Japan are recognition of the significant scientific advance this vaccine represents. It has shown over 90% efficacy across all age groups studied for the prevention of shingles, a painful and potentially serious disease that affects around one in three people," said Thomas Breuer, senior vice president & chief medical officer of GSK Vaccines.
Shingrix was approved in the US and Canada in October last year, and has been recommended by the US Centers for Disease Control & Prevention's Advisory Committee on Immunization Practices as the preferred vaccine for the prevention of herpes zoster and related complications for immunocompetent adults aged 50 years and older.
Glaxosmithkline (GSK)