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A U.S. Food and Drug Administration advisory panel on Wednesday voted 11-0 that the safety and efficacy of GlaxoSmithKline's Shingrix shingles vaccine warrants approval for its use in adults aged 50 and over.
Panel members said they were "very impressed" by the efficacy data from clinical trials of Shingrix, and that it represents an improvement over Zostavax, the current marketed shingles prevention vaccine from Merck & Co.
FDA - Advice - Expert - Panels - Approval
While the FDA is not required to follow the advice of its expert panels, it typically does so, with an approval decision expected in coming weeks.
Shingrix is considered one of the more important products in GSK's pipeline, with annual sales forecast to reach $1 billion by 2023, according to Thomson Reuters data.
Zostavax, approved in...
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