March 19 (Reuters) – Novo Nordisk said on Thursday the U.S. Food and Drug Administration has approved a higher dose of its blockbuster obesity drug Wegovy to reduce excess body weight and maintain weight reduction long term. The 7.2 milligram dose of Wegovy received a priority review voucher to speed up the review time, in […]
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US FDA approves higher dose of Novo’s Wegovy
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March 19 (Reuters) – Novo Nordisk said on Thursday the U.S. Food and Drug Administration has approved a higher dose of its blockbuster obesity drug Wegovy to reduce excess body weight and maintain weight reduction long term.
The 7.2 milligram dose of Wegovy received a priority review voucher to speed up the review time, in a first approval of a GLP-1 treatment under the Commissioner’s National Priority Voucher program.
The approval was based on results that showed patients who were given the 7.2 mg dose once weekly recorded 20.7% weight loss on average and about one in three people experienced 25% or greater weight loss.
Novo Nordisk expects to launch the higher dose of Wegovy in a single-dose pen in the U.S. in April.
The higher dose is already approved in the UK to be administered as three separate injections.
(Reporting by Sneha S K; Editing by Shilpi Majumdar)