Looking positive for Shingrix13 Sep 2017 22:46
Sept 13 (Reuters) - 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 efficacy data from Shingrix clinical trials, and that it represents an improvement over Zostavax, the only marketed shingles prevention vaccine from Merck & Co.
While the FDA is not required to follow recommendations of its advisory panels, the enthusiasm expressed would seem to indicate that approval is a virtual certainty 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.