SAXENDA, a Novo Nordisk diabetes drug used for treatment for obesity has received an approval by The Food and Drug Administration (FDA). It’s the first injectable drug approved for weight loss.
Saxenda is brand name for the drug, liraglutide, and is approved for obese adults and for overweight adults who have at least one weight-related health problem like type 2 diabetes, hypertension, or high cholesterol (dyslipidemia). It can be used as a treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity.
It can be used by any adult who has a body mass index (BMI) of 30 or greater (obesity) or adults with a BMI of 27 or greater (overweight).
“BMI is the measure of body fat based on an individual’s weight and height is used to define the obesity and overweight categories.”
Since obesity today has become a lifestyle disease with more and more people suffering from it, especially the youngsters. It has raised a public health concern and threatens the overall well-being of patients
According to James Smith, M.D., M.S., acting deputy director of the Division of Metabolism and Endocrinology Products in FDA’s Center for Drug Evaluation and Research:
“Saxenda, used responsibly in combination with a healthy lifestyle that includes a reduced-calorie diet and exercise, provides an additional treatment option for chronic weight management for people who are obese or are overweight and have at least one weight-related comorbid condition.”
The drug Saxenda belong to the class of drugs which are glucagon-like peptide-1 (GLP-1) receptor agonist and such drugs should not be used in combination with any other drug belonging to this class, including Victoza, a treatment for type 2 diabetes.
Saxenda and Victoza contain the same active ingredient (liraglutide) but in different doses (3 mg and 1.8 mg, respectively). However, for the treatment of type 2 diabetes, there is no indication of Saxenda as the safety and efficacy of Saxenda for the treatment of diabetes has not been established.
For evaluation of safety and efficacy of Saxenda, three clinical trials were conducted that included approximately 4,800 obese and overweight patients with and without significant weight-related conditions. All patients received counseling regarding lifestyle modifications that consisted of a reduced-calorie diet and regular physical activity.
The results from a clinical trial indicated that the enrolled patients without diabetes showed an average weight loss of 4.5 percent from baseline compared to the patients who received treatment with a placebo (inactive pill) at the end of one year.
According to the FDA the patients using Saxenda should be evaluated after 16 weeks to determine if the treatment is working. If a patient has not lost at least 4 percent of baseline body weight, Saxenda should be discontinued, as it is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment.
“The FDA approved Saxenda with a Risk Evaluation and Mitigation Strategy (REMS), which consists of a communication plan to inform health care professionals about the serious risks associated with Saxenda.”
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About Ruchira Dhoke
A qualified medical microbiologist with an avidity to read enchant a deep passion for creating a good impacting masterpiece with my words .I am very fond of good old English literature and like listening to music and paint in my free time.
