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Stock impact report

FDA approves new higher-dose version of Wegovy shots [Yahoo! Finance Canada]

Novo Nordisk A/S (NVO) 
Last novo nordisk a/s earnings: 2/5 01:31 am Check Earnings Report
US:NYSE Investor Relations: novonordisk.com/investors.html
The U.S. Food and Drug Administration approved a 7.2-milligram dose of Danish drugmaker Novo Nordisk's semaglutide. Previously, the highest approved dose of the drug, taken as a weekly shot, was 2.4 milligrams. The new dose received accelerated review through the FDA's ultra-fast drug review program. The approval was granted 54 days after the request for review was approved, the agency said in a statement. The new dosage will be available in April at pharmacies in the U.S., with a price to be announced then, according to the company. European drug regulators approved the higher-dose version of Wegovy in February. Called Wegovy HD, the higher-dose drug helped participants in a study lose about 19% of their body weight, or almost 47 pounds, versus about 16% of body weight, or 39 pounds with the lower dose over almost 17 months. The higher dose was developed because while the 2.4-milligram shot is effective, “some individuals do not reach their therapeutic goals” at that dose, Show less Read more
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