FDA Panel Votes Unanimously to Approve GSK Shingles Vaccine
Shingrix represents a new, possibly better alternative to existing treatments.
On Sept. 13, 2017, members of a US FDA advisory panel unanimously voted for approval of GlaxoSmithKline’s (GSK) new shingles vaccine, Shingrex, as a way to prevent shingles in adults age 50 and over. According to Reuters, reviewers voted 11 – 0 for approval of the vaccine, which Thomson Reuters analysts predict will achieve $1 billion in sales by 2023.
Shingrix contains an immune adjuvant, QS-21 Stimulon, developed by Agenus, that is said to boost efficacy. Shingles affects mainly older people, and results from reactivation of the varicella-zoster virus, which causes chickenpox and remains latent in those who have had that disease.
In clinical trials, the vaccine remained about 90% effective in patients over age 70, where other vaccines’ efficacy declined over time, Reuters reports.
Panelists questioned the incidence of certain reported adverse health issues among Shingrix recipients, including gout and stroke, according to Reuters, but GSK scientists do not believe that these were related to the compound, and have proposed launching a post-approval safety monitoring plan.
Newsletter
Stay at the forefront of biopharmaceutical innovation—subscribe to BioPharm International for expert insights on drug development, manufacturing, compliance, and more.
