GlaxoSmithKline announced that the FDA approved the company's shingles vaccine Shingrix for the prevention of herpes zoster in adults aged 50 years and older. Thomas Breuer, chief medical officer of GlaxoSmithKline Vaccines, remarked that the vaccine "has shown over 90 percent efficacy across all age groups in the prevention of shingles,"adding that "Shingrix was developed specifically to overcome the age-related decline in immunity."
An FDA advisory panel recently voted in favour of Shingrix for the prevention of herpes zoster in adults aged 50 years and over. The approval was based on data from clinical trials, including the ZOE-50 and ZOE-70 studies, evaluating the vaccine's efficacy, safety and immunogenicity. Meanwhile, results of the Zoster-048 study showed that Shingrix induced strong immune responses in patients with previous exposure to Merck & Co.'s shingles vaccine Zostavax.
GlaxoSmithKline noted that the vaccine, which contains Agenus' immune adjuvant QS-21 Stimulon, will be available shortly at a price of $280 for the required two doses. The vaccine is also under review for approval in the EU, Australia and Japan. Shingrix was recently approved in Canada for the prevention of shingles in people aged 50 years or older.
Analysts have forecast Shingrix' annual sales to reach $1 billion by 2023.
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