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Victoza 102 articles

Novo Nordisk Settles Whistleblower Complaints Alleging Victoza Fraud

Novo Nordisk has agreed to pay nearly $59 million to settle seven whistleblower lawsuits accusing the Danish multinational drug company of violating the Federal Food, Drug, and Cosmetic Act (FDCA) and False Claims Act (FCA) by downplaying the health risks of its diabetes drug Victoza. The U.S. Justice Department said Tuesday’s settlement settles allegations that Novo Nordisk fed information to doctors through its sales force that created false or misleading impressions that the U.S. Food and Drug Administration (FDA)-mandated warnings for Victoza were wrong or unimportant. After the FDA approved Victoza as a Type II diabetes treatment in 2010, it required ... Read More

FDA approves two new combination type 2 diabetes treatments

Two new treatments for type 2 diabetes were approved by the Food and Drug Administration (FDA), and both contain a combination of the same types of medications – an anti-diabetic drug from the GLP-1 receptor class, and a long-acting insulin. The approvals for both Sanofi’s LixiLan and Novo Nordisk’s IDegLira, were delayed for three months after being recommended for approval by FDA advisory panels last May. LixLan’s approval in the U.S. is its first worldwide for the combination treatment, which includes the GLP-1 receptor agonist lixisenatide (Lyxumia/Adlyxin)and the insulin glargine (Lantus). It is intended for patients with type 2 diabetes ... Read More

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

Pancreatitis rate dramatically increasing in recent years

Pancreatitis, a painful inflammation of the pancreas, is the most common cause of hospitalization for patients with a gastrointestinal disorder. The number of those afflicted with the condition has nearly doubled in the past two decades, with more than 40-60 new cases per 100,000 diagnosed each year. Researchers say the cause for the increase in pancreatitis is likely linked to the growing problem of obesity, which is strongly related to gallstones, as well as increasing amounts of alcohol consumption. Pancreatitis can be acute, meaning it occurs suddenly and usually resolves within days if treated in a timely manner, or chronic, ... 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