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FDA to review new combination diabetes drugs

French drugmaker Sanofi plans to redeem a fast-track voucher to gain accelerated regulatory review of its experimental combination diabetes drug Lixilan, a once-daily injectable treatment that combines its blockbuster insulin Lantus with Lyxumia, a Type 2 diabetes medication currently marketed in Europe. Lyxumia is not yet approved in the United States but is currently under review by the Food and Drug Administration (FDA). It is in a class of type 2 diabetes drugs known as GLP 1 receptor agonists. Other drugs in this class include the brand names Byetta and Victoza. Sanofi hopes to give Lixilan the edge over competitor ... Read More

Victoza heart risk data expected this year

Drug maker Novo Nordisk is weighing its options for releasing data from an important cardiovascular risk study involving its Type 2 diabetes medication Victoza, hoping the drug can show encouraging results in light of the unprecedented success of Eli Lilly and Boehringer Ingelheim’s diabetes drug Jardiance, which showed it cut cardiovascular death in patients by a staggering 32 percent. The Food and Drug Administration (FDA) has ordered manufacturers of newer type 2 diabetes drugs to conduct long-term post marketing studies on their diabetes medications focusing on cardiovascular effects. The ruling came after the agency severely restricted use of the diabetes ... Read More

Type 2 diabetics at greater risk of developing pancreatic, liver cancers

People with type 2 diabetes who were hospitalized at some point to treat their disease are at an increased risk of developing certain types of cancer, a new study has found. Researchers at Lund University in Sweden; Germany Cancer Research Center in Heidelberg, Germany; and Stanford University in California analyzed data from a national Swedish database and found type 2 diabetics were more likely to have cancer. The most common cancers among these patients affected the colon, liver, pancreas, endometrium, and kidney. The risk for pancreatic cancer and liver cancer in these patients was particularly high, the researchers noted. Pancreatic ... Read More

Weekly, daily versions of diabetes drugs have similar risk-benefit profile

Once-weekly versions of a popular class of type 2 diabetes drugs carry a similar risk-benefit profile as daily-dose versions of drugs in the same class, a new study has found. The study involved type 2 diabetes drugs known as glucagon-like peptide-1 receptor agonists, or GLP1 agonists. The drugs are designed to improve blood sugar control, but also carry the attractive side effect of weight loss. Obesity and being overweight are risk factors for type 2 diabetes. All are administered by injection. GLP1 agonists include the brand names Byetta (exenatide) and Victoza (liraglutide), which are administered once or twice daily; and ... Read More

Victoza claims better efficacy than Invokana

Novo Nordisk is taking great efforts to stretch the profit-earning potential of its blockbuster type 2 diabetes drug Victoza. The company won approval to market the drug as an obesity treatment under the brand name Saxenda, and has launched clinical trials to test the drug as a treatment for nonalcoholic fatty liver disease, one of the most common causes of chronic liver disease. Now the company is taking aim at its competitors in the lucrative diabetes market, rolling out a new meta-analysis showing that Victoza was superior at reducing blood sugar metric HbA1c (a more accurate test for diabetes control) ... Read More

Novo Nordisk could reap billions from experimental diabetes pill

Drug maker Novo Nordisk has enjoyed booming profits from its injectable diabetes treatment Victoza, thanks to winning approval for a potent version of the drug, marketed as Saxenda, as an obesity treatment. But it’s new oral version of a diabetes drug from the same class as Victoza could send profits as high as $20 billion per year. In the pharmaceutical industry, drugs that reap annual profits of at least $1 billion are called blockbusters. There is a special term for a drug that exceeds $10 billion in sales – super-blockbuster, says Seeking Alpha. These drugs are few and far between, ... Read More

Novo Nordisk tests new type 2 diabetes treatment

Drug maker Novo Nordisk’s experimental, once-weekly type 2 diabetes treatment semaglutide is effective at lowering blood sugar levels and triggering weight loss in phase III study participants. However, the drug did have a higher dropout rate – 5 to 6 percent – due to side effects. Semaglutide is a GLP-1 analogue, which is the same class as the diabetes treatments Byetta, Bydureon, and Victoza, the latter of which is also made by Novo Nordisk. Like Byetta, Bydureon and Victoza, semaglutide is administered by injection. Novo Nordisk also has an oral version of semaglutide, which is currently in phase II clinical ... Read More

Victoza fails to improve health in heart failure patients

Novo Nordisk has made great strides to expand the indication of its type 2 diabetes drug Victoza by gaining approval for a high-dose version as a weight loss treatment, marketed as Saxenda. The company is also testing the drug as a treatment for nonalcoholic fatty liver disease. But a new study found the drug ineffective in patients with advanced heart failure. Heart failure is a chronic condition in which the heart does not pump enough blood through the body. About 5 million Americans have heart failure. The study sought to find whether Victoza, known chemically as liraglutide, could correct defects in ... Read More

Patients with Type 2 diabetes sought for clinical trial comparing medications

More than 50 medical centers associated with universities across the country are recruiting patients with type 2 diabetes to participate in a five-year study to determine the best prescription drug to treat high blood sugar. The study is being conducted by National Institute of Diabetes and Digestive and Kidney Diseases. A total of 5,000 participants is being sought. Those who wish to join the clinical trial should have been diagnosed with type 2 diabetes within the past 10 years and currently be taking the widely used anti-diabetes drug Metformin. Those who are accepted into the program will receive compensation for their ... Read More

Victoza studied in obese patients with pre-diabetes

People who are obese and pre-diabetic can lose weight and delay the onset of type 2 diabetes by more than three years if they take a newer diabetes medication, according to a study presented at ObesityWeek 2015. However, the medication puts users at risk for dangerous side effects. The study involved the type 2 diabetes drug liraglutide, known by the brand name Victoza, which was approved by the Food and Drug Administration (FDA) in 2010. In December 2014, the agency approved a higher dose of the drug, marketed as Saxenda, for weight loss in obese non-diabetics, and for overweight patients ... Read More