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obesity drug 9 articles

High-dose diabetes drug Victoza to be sold as obesity drug Saxenda

A high-dose version of Novo Nordisk’s type 2 diabetes drug Victoza, containing the active ingredient liraglutide, has been approved by the Food and Drug Administration (FDA) to treat obesity. The new diet drug will be marketed by Novo Nordisk under the brand name Saxenda. Like Victoza, the new weight loss treatment comes as in injectable drug and is intended for patients with a body mass index (BMI) of 30 or higher and at least one weight-related health condition, such as diabetes. Novo Nordisk believes Saxenda has the potential to be a blockbuster medication, generating sales of more than a billion dollars ... Read More

FDA panel recommends approving diabetes treatment for obese patients

A Food and Drug Administration (FDA) advisory panel has given a thumbs-up recommendation to Novo Nordisk’s type 2 diabetes drug liraglutide for the treatment of chronic obesity in patients with at least one weight-related health issue, such as hypertension or pre-diabetes. Liraglutide, known commercially as Victoza, would be sold under the label Saxenda for the obesity indication if it is approved by the FDA. The agency is not required to follow the recommendations of its advisory panels, but it usually does. The positive recommendation was based on a clinical trial in which patients were given 3 mg of liraglutide. About ... Read More

FDA delays decision on diet pill based on heart risk evaluation

The Food and Drug Administration (FDA) has delayed its decision by three months on the new diet pill contrave in order to reach an agreement with drug company Orexigen Therapeutics regarding post-marketing obligations related to the evaluation of cardiovascular risks associated with the drug. Orexigen and the FDA are currently in talks about the package insert and other post-marketing requirements. The FDA had rejected the drug in 2011, saying it needed more studies to put to rest concerns about heart risks. Orexigen came back nearly three years later with an analysis involving 8,900 patients showing patients taking contrave did not ... Read More

Type 2 diabetes drug Victoza tested as potential diet drug

The type 2 diabetes drug Victoza (liraglutide) can help overweight and obese people without diabetes lose weight, according to a new multinational clinical trial, but the drug comes with some risks. Victoza, an injectable drug in a class of diabetes medications known as glucagonlike peptide-1 (GLP-1) agonist, was approved by the Food and Drug Administration (FDA) in January 2010 to help lower blood sugar levels in people with type 2 diabetes. In an effort to expand the indication to non-diabetics who are overweight, the medication was pitted against a placebo and the currently marketed anti-obesity drug Qsymia, a combination of ... Read More

Tainted dietary supplements seized by federal agents

Tainted dietary supplements made by Globe All Wellness (Globe All), in Hollywood, Fla., were seized by U.S. Marshals acting on behalf of the Food and Drug Administration (FDA) because the products contain an undisclosed active pharmaceutical ingredient and may be unsafe. Several of the seized products contain sibutramine hydrochloride (sibutramine), the active ingredient in the obesity drug Merida. In December 2010, the FDA pulled Meridia from the U.S. market after clinical data showed the drug increased the risk for heart attacks and strokes. Globe All claims its products can lower blood pressure and cholesterol, as well as improve other health ... Read More

Drug company wants to speed review process for new diet drug Contrave

Orexigen Therapeutics Inc. is hoping the Food and Drug Administration (FDA) will grant its request to speed up the review process for its obesity drug Contrave. The agency rejected the weight loss drug in February 2011, saying it needed data from a large-scale study on the long-term cardiovascular effects associated with the medication before approval would be granted. Contrave is a combination of two medications already approved by the FDA – bupropion, which is the active ingredient in the antidepressant Wellbutrin, and the anti-addiction drug naltrexone. Contrave is designed to influence the hypothalamus in order to decrease food intake over ... Read More

Trial on experimental obesity drug halted after participant suffers serious reaction

Astra Zeneca and Palatin Technologies have halted a phase 1 trial of an experimental obesity drug after a participant in the study suffered a severe adverse event. The drug, known as AZD2820, is a melanocortin-4 receptor partial agonist. Mutations in the melanocortin-4 receptor have been associated with inherited human obesity, and is the most commonly known genetic defect predisposing people to obesity. It is suspected that the participant may have suffered from an allergic reaction to the medication. A spokesperson with Palatin says the man who fell ill after taking the drug fully recovered and that the company “will work ... Read More

Qsymia makers worry generics may take bite out of profits

Makers of the new obesity drug Qsymia have significantly scaled back their profit expectations after concerns that doctors may prescribe the drug’s ingredients separately rather than the drug itself. Vivus Inc., had estimated profits of as much as $3.6 billion per year, but scaled back its estimate to $1.2 billion, causing Vivus shares to tumble 7.7 percent earlier this week. Qsymia was one of two new long-term diet drugs approved by the Food and Drug Administration (FDA) earlier this year, making the drugs the first weight loss medications to be approved in 13 years. Qsymia was thought to be the ... Read More

FDA delays vote on experimental diet drug Qnexa

Approval for the experimental weight loss drug Qnexa has been pushed back another three months, paving the way for other drugs to stretch ahead in the race for the first diet pill in 13 years to be granted marketing rights in the United States. The Food and Drug Administration (FDA) pushed back the target date for approval to allow time to review a new safety plan submitted by drug maker Vivus Inc. These plans often include information that explains side effects and safety risks. Side effects reported with Qnexa include birth defects, heart palpitations, suicidal thoughts, and memory lapses. Vivus ... Read More