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[HEALTH] · Brazil · 12 sources

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Anvisa approves oral Wegovy for obesity treatment in Brazil

Brazil’s National Health Surveillance Agency (Anvisa) has approved the registration of Wegovy (semaglutide) in oral tablet form. This marks the first time a GLP-1 receptor agonist has been authorized for oral administration in the country to treat obesity and overweight conditions in adults.

Produced by Novo Nordisk, the medication is intended for use alongside a healthy diet and physical activity. The oral version follows a progressive dosage schedule, starting at 1.5 mg and increasing to 4 mg and 9 mg, until reaching a recommended daily maintenance dose of 25 mg. The tablets must be taken once daily on an empty stomach with a small amount of water, followed by a 30-minute wait before consuming food or other substances.

The approval is supported by the phase 3 OASIS 4 clinical study, which showed that participants receiving the 25 mg dose experienced an average body weight loss of over 13% during a 64-week period. This new format offers increased therapeutic flexibility, allowing healthcare professionals to transition patients between oral and subcutaneous injectable formulations when clinically appropriate. The medication is expected to be available in Brazilian pharmacies in the coming months.

Entities

Anvisa · Biocon · Brazil · Novo Nordisk · OneSource Specialty · Wegovy · semaglutide