Liraglutide FDA Approval Brings First Ever Injectable Weight Loss Drug


Liraglutide FDA Approved As 1st Ever Injectable Weight Loss DrugThe close of 2014 brought exciting news for Novo Nordisk’s innovative weight loss drug Saxenda. The Liraglutide FDA approval is the first of its kind as it’s the only available injectable treatment for obesity. The FDA overwhelmingly gave a nod to this easy to use form of Liraglutide as a safe and effectual option for patients suffering from obesity and in need of medical weight loss. Already approved in 2010 by the FDA for Type 2 Diabetes as the trade name Victoza, Liraglutide has proven to be an efficacious product aimed at combating the most common cause of diabetes worldwide. The newly approved Saxenda will contain a greater amount of Liraglutide than its initial product, Victoza, and it is designed to be an effective GLP-1 agonist that will promote weight loss and weight control.

The increase of obesity globally has become a serious and costly epidemic. Chronic management of obesity is called for, with treatments like Liraglutide considered to be a positive step in the right direction. As of 2015 one-third of adults in the United States are estimated to be classified as obese. The Liraglutide FDA approval of Saxenda (rDNA origin injection) is specifically endorsed as an adjunct treatment for chronic weight management alongside both increased physical activity and a healthy diet. Liraglutide works for weight control by sending a message of satiety to the center of the brain, which in turn slows down the stomach. Liraglutide has been documented in clinical trials to work exceptionally well at controlling hunger especially during the initial weeks of treatment, which naturally parlays to early weight loss and feelings of success amongst patients.

A landmark clinical trial which involved patients who were classified as obese but who were not diabetic showed an average yearly weight loss of 4.5 percent, as compared to a placebo. Approximately 49 percent of the patients who received Liraglutide as Saxenda lost at least 5 percent of their body weight. The dosage of Liraglutide is 3.0 milligrams per day, which is considerably higher than the dosing for patients with Type 2 Diabetes, which is between 1.2 milligrams and 1.8 milligrams daily. Adverse effects proved to be rare amongst trial participants. Common side effects reported were nausea and upset stomach, however no patient ended their participation due to these effects.

Another pivotal study, coined SCALE™, or Satiety and Clinical Adiposity−Liraglutide Evidence in Non-diabetic and Diabetic adults, proved to be noteworthy in the phase 3 clinical trial segment. Over 5,000 patients were enrolled in this trial, who were considered to be either obese or overweight. All patients exhibited various comorbidities associated with their condition. The use of Liraglutide for participants in this trial, combined with a reduced calorie diet and active exercise resulted in decidedly greater weight loss as compared to diet and exercise alone. Additionally, patients involved in the aforementioned study were able to gain control over weight related comorbid conditions, such as hypertension, high glycemic levels and dyslipidemia. Patients are advised to avoid the use of Liraglutide as Saxenda for weight control if they are currently using insulin, have or have had pancreatitis or are taking other products to promote weight loss.

LGM Pharma can assist clients as a supplier/distributor of the API Liraglutide, CAS # 204656-20-2, for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

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