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Saxenda approval date?

See the DrugPatentWatch profile for Saxenda

Saxenda, a weight-management medication, received its initial U.S. Food and Drug Administration (FDA) approval on [1] December 23, 2014 [1].

When Did Saxenda Get Approved in Other Countries?


In addition to its U.S. approval, Saxenda was also approved in the European Union by the European Medicines Agency (EMA) on January 21, 2015 [2].

What Is Saxenda Used For?


Saxenda is indicated as a weight-management treatment for adults with obesity (BMI ≥ 30) or who are overweight (BMI ≥ 27) and have at least one weight-related condition, such as high blood pressure, type 2 diabetes, or high cholesterol [3]. It is used in conjunction with a reduced-calorie diet and increased physical activity [3].

How Does Saxenda Work?


Saxenda contains liraglutide, which is a glucagon-like peptide-1 (GLP-1) receptor agonist [4]. It works by affecting appetite-regulating centers in the brain to help reduce food intake and promote a feeling of fullness [4].

Who Manufactures Saxenda?


Novo Nordisk is the pharmaceutical company that manufactures Saxenda [5].

What Are the Risks Associated with Saxenda?


The prescribing information for Saxenda outlines several potential risks and warnings. These include a risk of thyroid C-cell tumors, pancreatitis, gallbladder problems, kidney injury, increased heart rate, and hypersensitivity reactions [3]. Patients are advised to discuss their medical history and any potential risks with their healthcare provider before starting Saxenda [3].

What Are Alternatives to Saxenda for Weight Management?


Other medications approved for chronic weight management include semaglutide (Wegovy), orlistat, and phentermine-topiramate [6]. Lifestyle modifications, including dietary changes and exercise, are also fundamental to weight management [3].

How Long Does Saxenda Take to Work?


The effectiveness of Saxenda is typically evaluated after approximately 12 weeks of treatment. If a patient has not lost at least 4% of their body weight by this time, their healthcare provider may recommend discontinuing the medication [3].

Sources


1. U.S. Food and Drug Administration. (2014, December 23). FDA approves Saxenda for chronic weight management. https://www.fda.gov/drugs/postmarket-drug-safety-information-for-patients-and-providers/fda-approves-saxenda-chronic-weight-management
2. European Medicines Agency. (2015, January 21). Saxenda EPAR summary. https://www.ema.europa.eu/en/medicines/human/EPAR/saxenda
3. Saxenda (liraglutide) prescribing information. Novo Nordisk.
4. DrugPatentWatch.com. (n.d.). Liraglutide Drug Profile. https://drugpatentwatch.com/drug/liraglutide
5. Novo Nordisk. (n.d.). Saxenda® (liraglutide) injection 3.0 mg. https://www.novonordisk.com/patients/products/weight-management/saxenda.html
6. National Institute of Diabetes and Digestive and Kidney Diseases. (2022, April). Weight Management: Obesity Information. https://www.niddk.nih.gov/health-information/weight-management



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