An FDA advisory panel on Wednesday voted 11-0 in favour of GlaxoSmithKline's candidate shingles vaccine Shingrix for the prevention of herpes zoster in adults aged 50 years and over, the drugmaker announced. Chief medical officer of GSK Vaccines Thomas Breuer remarked "this is a new generation of vaccine, which really has overcome the age-related decline in immunity."
GlaxoSmithKline's marketing application of the therapy was backed by findings from clinical trials including the ZOE-50 and ZOE-70 studies. Meanwhile, results of the Zoster-048 study presented in June showed that Shingrix induced strong immune responses in patients with previous exposure to Merck & Co.'s shingles vaccine Zostavax.
The FDA is expected to issue a final decision regarding whether to approve Shingrix later this year, with GlaxoSmithKline expected to announce a US price following regulatory clearance. The vaccine, which contains Agenus' immune adjuvant QS-21 Stimulon, is also under review for approval in the EU, as well as Australia, Canada and Japan.
Analysts have forecast sales of $1 billion for Shingrix by 2023.
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