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Byetta 204 articles

Sanofi ready to submit new type 2 diabetes drug for approval

After years of delay, drug maker Sanofi is almost ready to resubmit its type 2 diabetes treatment lixisenatide for Food and Drug Administration (FDA) approval, armed with a long-term study that the company hopes will squash any safety concerns posed by FDA panel advisors. Lixisenatide, which is already approved in Europe and marketed under the name Lyxumia, is a GLP-1 agonist that works similarly to already marketed drugs Byetta and Victoza. The drug was originally under review by an FDA advisory panel in 2013, but after Novo Nordisk’s GLP-1 drug was rejected due to safety concerns, Sanofi opted to pull lixisenatide’s ... Read More

Alarming number of pancreatitis, pancreatic cancer cases with diabetes drugs

Pancreatitis is a painful inflammation of the pancreas that can increase the likelihood of a patient developing pancreatic cancer, a health problem that type 2 diabetics are already at greater risk of developing. Interestingly, a study of drug adverse event reports reveals that common type 2 diabetes drugs have been associated with side effects that include acute pancreatitis and pancreatic cancer. Health informatics firm AdverseEvents scoured through post-marketing reports filed with the Food and Drug Administration (FDA) and found 1,900 cases of pancreatitis with AstraZeneca’s Byetta injection, 1,284 cases in patients taking Novo Nordisk’s Victoza, and 1,296 cases in patients ... Read More

Diabetes drugs may help reduce craving, but patients risk side effects

A class of type 2 diabetes drugs appear to change the brain’s response to food, leading to weight loss, and could also help people fight cravings for drugs, alcohol and nicotine as well, researchers suggest. The class of drugs, known as GLP-1 receptor agonists, or GLP-1 drugs, are known by the brand name diabetes treatments Bydureon, Byetta and Victoza. Since weight gain is already a contributing factor to the development of type 2 diabetes, the weight loss side effect offered by GLP-1 drugs is attractive. Late last year, Novo Nordisk received FDA approval for Saxenda, a high-dose version of its ... Read More

European regulators to review serious metabolic side effects with diabetes drugs

The European Medicines Agency (EMA) announced it will review the risk of a life threatening metabolic condition known as ketoacidosis from the use of certain type 2 diabetes drugs known as SGLT2 inhibitors. The review comes just after the U.S. Food and Drug Administration (FDA) ordered that warnings be placed on the labels of SGLT2 drugs advising patients and doctors of this risk. Ketoacidosis is a serious diabetes complication where the body produces excess blood acids, or ketones. It can lead to diabetic coma or death. It generally occurs when insulin levels are too low or during prolonged fasting. However, ... Read More

Diabetes drug Victoza being tested as treatment for fatty liver disease

Drug maker Novo Nordisk continues to look for new uses for its type 2 diabetes drug Victoza despite serious side effects including pancreatic cancer. The drug company is currently testing Victoza as a treatment for fatty liver disease, a condition for which treatments are limited. Victoza, which contains the active ingredient liraglutide, was shown to resolve fatty liver disease in more than a third of patients who participated in a small phase II study conducted by researchers from University of Birmingham in Britain. Fatty liver disease is the accumulation of fat on the liver that causes inflammation and scarring. It ... Read More

Weight loss from newer diabetes drugs may come at steep price

Newer classes of type 2 diabetes drugs can help patients lose weight, but that benefit may come at a high price. Being overweight is a risk factor for type 2 diabetes. Patients diagnosed with the chronic disease are generally advised to adopt a healthy diet and get regular exercise to help keep their blood sugar levels in check. Uncontrolled diabetes can increase the risk of serious health problems including heart disease, kidney disease, some cancers, blindness, neuropathy, and dementia. Losing weight through diet and exercise can help diabetics better manage and, in some cases, fend off the disease. However, reaching ... Read More

FDA grants Fast Track status to advance pancreatic cancer drug

Merck and Threshold Pharmaceuticals’ experimental cancer drug evofosfamide has been granted Food and Drug Administration (FDA) Fast Track Designation for the treatment of advanced pancreatic cancer, a classification designed to accelerate the approval process for medications that treat serious or life-threatening diseases and fill an unmet medical need. Evofosfamide, previously known as TH-302, works by attacking body tissue that is short of oxygen supply, a characteristic of many cancer tumors because the cells often grow without connecting to the blood vessels around them. The medication is currently being tested in the third and last phase needed for FDA approval. Evofosfamide ... Read More

Study: Overweight diabetics live longer than normal weight diabetics

Type 2 diabetics who are overweight – but not obese – live longer than diabetics of normal weight, according to a new study published in the Annals of Internal Medicine. The so-called “obesity paradox,” which counters the conventional wisdom that maintaining a healthy weight will prolong life, has been seen with other health conditions. For example, studies have shown that while obesity increases the risk of developing cardiovascular disease, overweight patients with the condition outlive normal weight patients with heart disease. And, to confuse matters more, obesity increase the risk of developing type 2 diabetes. The new study on mortality ... Read More

Type 2 diabetes drugs linked to pancreatic cancer

Sandy LaRosa blames her husband’s painful death from pancreatic cancer on his type 2 diabetes drug. Tom, 72, had been taking the 1.8 mg dose of Victoza since 2010 to help manage his type 2 diabetes. Victoza had also been associated with weight loss, which was of particular interest to Tom, who had been battling obesity for years. Last August, however, Tom developed stomach problems. His doctor ordered a blood test that showed possible inflammation of his pancreas. His doctors took him off Victoza because the drug had been linked to a painful inflammation of the pancreas known as acute pancreatitis. The ... Read More

Study: Metformin does not improve survival of pancreatic cancer patients

Metformin, the widely used first-line treatment for type 2 diabetes, did not prolong the life of pancreatic cancer patients, according to a retrospective cohort study presented at the AACR Annual Meeting. Pancreatic cancer is a devastating disease with the highest mortality rate among all major cancers. Ninety-four percent of patients with the disease die within five years of diagnosis. Type 2 diabetics are at an increased risk of developing the deadly disease. And many drugs to treat diabetes, including Januvia and Byetta, can increase a patient’s risk of developing acute pancreatitis and pancreatic cancer. Previous epidemiologic research, however, has suggested ... Read More