The European Medicines Agency on Friday said its Committee for Medicinal Products for Human Use recommended approval for GlaxoSmithKline's marketing application for Shingrix for the prevention of herpes zoster and post-herpetic neuralgia in adults 50 years of age or older. A final decision by the European Commission is anticipated in April.
The agency indicated that the benefits of Shingrix include "its ability to significantly decrease the incidence of herpes zoster and consequently of post-herpetic neuralgia compared with placebo." The EMA noted that the vaccine combines the varicella zoster virus glycoprotein E antigen with the adjuvant AS01B and is designed to induce antigen-specific cellular and humoral immune responses in individuals with pre-existing immunity against varicella zoster virus.
Thomas Breuer, chief medical officer of GlaxoSmithKline's vaccines division, noted that "the risk of developing shingles increases with age and it is estimated that around one in three people will develop shingles in their lifetime." He added that the vaccine, which analysts estimate will generate annual sales of 1 billion pounds ($1.4 billion) by 2023, is "designed to overcome the age-related weakening of the immune system and is an important step forward in the prevention of shingles."
In October, the FDA approved Shingrix for the prevention of herpes zoster in adults at least 50 years of age. The decision was based on a review of data from the ZOE-50 and ZOE-70 studies, as well as results from the Zoster-048 trial, which demonstrated that Shingrix induced strong immune responses in patients with previous exposure to Merck & Co.'s shingles vaccine Zostavax.
Following approval in the US, the Centers for Disease Control and Prevention's advisory committee on immunisation practices voted 8-7 to recommend usage of Shingrix for the prevention of herpes zoster over Zostavax. Shingrix has also been authorised by regulators in Canada, while marketing applications are under review in Australia and Japan.
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