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Thread: Diabetes advances, research & treatments

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    waltky's Avatar Senior Member
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    FDA staff question utility of Novo Nordisk combo diabetes drug
    May 20, 2016 - A preliminary review by the U.S. Food and Drug Administration of Novo Nordisk A/S's experimental diabetes drug, IDegLira, questioned the interpretability of the study findings and practical use of the treatment, according to a review posted on the agency's website on Friday.
    The review comes ahead of a May 24 meeting of an FDA advisory panel that will discuss the drug and make recommendations as to whether it should be approved. The FDA is not obliged to follow the advice of its advisory panels but typically does. The drug combines Novo's drug Tresiba, known also as insulin degludec, with its GLP-1 agonist Victoza, known also as liraglutide. The company is seeking FDA approval for the combination product, IDegLira, to improve glycemic control in adults with type 2 diabetes. The drug was approved in Europe in 2014 under the brand name Xultophy.

    On May 25 the advisory committee will consider a similar drug, Sanofi SA's iGlarLixi, which combines the company's experimental GLP-1 agonist lixisenatide with its insulin treatment Lantus, also known as insulin glargine. The two companies' products would be the first to combine a GLP-1 and a basal insulin in a single injection. The idea is to treat patients earlier with a combination drug rather than waiting for patients to lose control of their blood sugar on one drug before moving to another. In its review of Novo Nordisk's drug, the FDA said, "The enhanced convenience that derives from combining two products into one dosage form generally comes at the cost of loss of dosing flexibility."


    Employees stand in the insulin production plant of Danish multinational pharmaceutical company Novo Nordisk in Chartres, north-central France

    The FDA reviewers found no new safety issues with IDegLira that were not already known for degludec and liraglutide but said, "It is important to note that use of IDegLira would expose patients to safety risks associated with both products." The reviewers also said the use of IDegLira allows for lower doses of liraglutide than have been proven efficacious while incurring safety risks associated with liraglutide use. The reviewers said there were limitations with the clinical trials that make the results difficult to interpret.

    Diabetes is a chronic metabolic disorder characterized by abnormally high blood sugar levels that can lead to blindness, heart disease and other serious conditions. Lixisenatide was approved by regulators in Europe and Japan in 2013 and is sold under the brand name Lyxumia. Sanofi licensed lixisenatide from Denmark's Zealand Pharma A/S.

    https://www.yahoo.com/news/fda-staff...ce.html?ref=gs
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    FDA targets sugar in new labeling rules
    May 20, 2016) - The U.S. Food and Drug Administration said it would update guidelines for nutritional labels on packaged food and beverages to include information on added sugar and to prominently display calorie count and servings.
    The move comes at a time the United States is staring at increasing childhood and adult obesity and lifestyle diseases such as heart problems. The FDA said on Friday that the modified guidelines, which companies would have to adopt within two years, would help consumers "make informed decisions about the foods they eat and feed their families." (http://1.usa.gov/1ODAIin) "What and how much people eat and drink has changed since the last serving size requirements were published in 1993," the FDA said.

    Currently, companies are required to provide details on the total amount of sugar in a product. Under the modified guidelines, they will have to break down details on the amount of added sugar such as corn syrup and white and brown sugar.

    Information about "Calories from Fat" will be removed because research shows the type of fat is more important than the amount, the FDA said. According to Centers for Disease Control and Prevention, more than a third of U.S. adults are obese. First Lady Michelle Obama, who has used her White House position to launch the "Let's Move" campaign to fight childhood obesity, had called for the changes two years ago.

    https://www.yahoo.com/news/fda-modif...or.html?ref=gs
    Last edited by waltky; 05-20-2016 at 11:15 AM.

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