Dec 12 (Reuters) – Novo Nordisk said on Friday the European Medicines Agency’s committee had issued a positive opinion for a higher dose of its popular weight-loss drug Wegovy, providing an option for greater weight loss. If cleared, the higher dose of 7.2 mg would expand options for patients and physicians beyond the currently approved […]
Health
EU drugs regulator backs higher dose of Novo’s Wegovy
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Dec 12 (Reuters) – Novo Nordisk said on Friday the European Medicines Agency’s committee had issued a positive opinion for a higher dose of its popular weight-loss drug Wegovy, providing an option for greater weight loss.
If cleared, the higher dose of 7.2 mg would expand options for patients and physicians beyond the currently approved 2.4 mg formulation.
The company has been facing growing rivalry from Eli Lilly, as its weight-loss drugs have surged in popularity, fueling demand for more potent options.
Novo’s product and portfolio strategy head, Ludovic Helfgott, said the higher dose could be available by early next year, pending the European Commission’s final approval.
The European Commission usually follows the EMA’s recommendation.
In a 72-week late-stage trial involving 1,407 adults without diabetes, participants on the 7.2 mg dose lost an average of 20.7% of body weight, compared with 17.5% for the 2.4 mg dose.
The company added that 84% of the weight reduction was fat mass, with tests indicating preserved muscle function, and reiterated Wegovy’s established benefits on reducing major cardiovascular events and alleviating knee osteoarthritis pain.
The higher dose is also under review in the U.S., the UK and several other countries. Novo Nordisk submitted the dose to the U.S. Food and Drug Administration in November under an expedited programme, with a decision expected within a month or two after the filing is accepted.
(Reporting by Puyaan Singh in Bengaluru; Editing by Shinjini Ganguli)