GlaxoSmithKline said Monday that it submitted a marketing application to the FDA seeking approval of its candidate shingles vaccine Shingrix for the prevention of herpes zoster in people aged 50 years or over. The company added that regulatory submissions in the EU and Canada are on track for this year and planned for Japan in 2017.
According to GlaxoSmithKline, its application in the US, which seeks clearance for the vaccine to be given intramuscularly in two doses, with a two to six month interval between doses, is supported by a Phase III programme involving more than 37 000 subjects. Results from the studies, which include the ZOE-50 and ZOE-70 trials, showed that by reducing the incidence of shingles, Shingrix also reduced the overall incidence of postherpetic neuralgia.
Last month, GlaxoSmithKline reported detailed results from the Phase III ZOE-70 study of Shingrix, demonstrating that the 90-percent efficacy observed in adults aged 70 years and older was maintained for at least four years. Shingrix is a non-live, recombinant vaccine to help prevent herpes zoster and its complications and combines glycoprotein E, a protein found on the varicella zoster virus that causes shingles, with an adjuvant system, AS01B, which is intended to enhance the immunological response to the antigen.
GlaxoSmithKline previously highlighted Shingrix as one of up to 20 new products that could be submitted for regulatory approval by 2020. Analysts predict that if approved, the product could generate sales of 638 million pounds ($781 million) by 2020, rising to 856 million pounds ($1 billion) in 2021.
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