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Lilly had delayed applying for marketing the treatment —basal insulin peglispro — earlier in the year, after studies reported an increase in liver fat in patients. A severe buildup of fats in the liver can cause inflammation and scarring of the organ, and progress to liver failure.
However, the company has said peglispro was not associated with the increase in liver enzymes. The drugmaker said on Friday that the decision was based on discussions with regulators and external experts. Lilly had developed peglispro as a long-acting treatment for type 1 diabetes and the more common type 2 diabetes.
Nearly 12 in 1000 Americans are diagnosed with diabetes every year, according to the Centers for Disease Control and Prevention. Eli Lilly's shares closed at $83.06 on Thursday.
Lilly stops development of diabetes treatment
Sue York - who has had type-1 diabetes since she was seven - would shake uncontrollably and vomit when injecting herself with insulin. Ms York told the BBC's Victoria Derbyshire programme the operation had "completely altered my life". Doctors said her life expectancy had now doubled.
'Full of energy'
Ms York, 55, from Lincoln, told the programme that, following the operation, at Manchester Royal Infirmary, she felt "incredible" and full of energy. "No longer am I struggling to walk up a flight of stairs, getting breathless walking into the wind. No longer is my skin yellow or grey. No longer do I look constantly exhausted," she said. "I've had to get new glasses because my eyesight has improved and feeling has returned to areas on my feet where I'd begun to lose sensation."
Ms York said her phobia had reached a critical point in 2012, when the DVLA had changed its regulations in relation to diabetic drivers, insisting they checked blood glucose levels - requiring her to prick her skin - before driving and once every two hours behind the wheel. "It was just too many needles, too many invasions into the flesh," she said.
Ms York had decided to give up driving, she said, but her body had been too weak to walk long distances - leaving her at risk of becoming housebound. She had tried hypnotherapy and cognitive behavioural therapy in an attempt to cure her phobia, but without success. And injecting herself with insulin would frequently take 20 minutes.
Questions raised
In general, people around the world are eating better and living longer, but they are also moving less. This is contributing to the rise of diabetes, a condition that affects 422 million people and is fast becoming a major problem, especially in poor countries. Two factors are critical for the successful treatment of diabetes patients. First is a correct diagnosis of the type of the disease, and second is the administration of the appropriate drugs.
A misdiagnosis and, consequently, the wrong treatment can cause many problems. “If you label someone who actually has type 2 diabetes as type 1, they'll be left on insulin for the rest of their life when they don't need it," said Dr. Richard Oram of the U.K. National Institute for Health Research. "Even worse, if someone with type 1 diabetes is mislabeled as having type 2 diabetes, then they may not be treated with the insulin they need, and they may suffer life-threatening complications.”
A new, less expensive test, developed at the University of Exeter Medical School, measures 30 genetic variants in the patient’s DNA and calculates the risk for type 1 or type 2. Individual diagnoses can be completed with a commonly used test for antibodies. Scientists are now trying to develop an even simpler DNA-based test that could be done with a smartphone app.
No more injections?
In the meantime, researchers in South Korea are developing a nanotechnology-based adhesive strip that takes away pain and stress of daily injections for diabetes patients. “The device is a patch type that enables [diabetics] to monitor blood sugar levels via sweat without taking blood samples and injections, as well as to control glucose levels by injecting medication,” said Kim Dae-hyeong, a professor in the School of Chemical and Biological Engineering at Seoul National University.
The patch is studded with microneedles that painlessly enter subcutaneous tissue. When the connected chip senses that the level of glucose has risen above normal, a small heating element dissolves medication and releases it into the bloodstream. Tests done on lab mice were promising, so scientists hope they will soon start testing the patch on humans. In this phase, experiments are still expensive, but scientists say the price will drop once it the patch is ready for mass production.
Scientists Creating New Devices to Battle Diabetes
The release of this report in advance of World Health Day (April 7) is meant as a call to global action to halt the rise of type 2 diabetes, which is killing 1.5 million people a year. The World Health Organization estimates 43 percent of these deaths occur prematurely, before the age of 70. The U.N. agency says diabetes is no longer a disease of the wealthy. Most cases now are found in middle- and low-income countries. The WHO says the highest rates are in the Middle East, Southeast Asia and the western Pacific. The WHO report says the dramatic rise of this deadly disease is largely due to the increasing number of overweight and obese people. It reports more than one in three adults is overweight and more than one in 10 is obese.
Diabetes in Africa, 2011 - 2030
Complications from diabetes
Etienne Krug, director of WHO's Department for Management of Noncommunicable Diseases, says diabetics will suffer complications from the disease if it is not detected in a timely manner and treated. “People with diabetes have a two to three times higher risk of cardiovascular disease," said Krug. "They have a 10 to 20 times higher risk of lower limb amputation. Diabetes is an important cause of blindness ...and an important cause of end stage renal disease.”
Obesity is among the main causes of type-two diabetes.
Krug tells VOA the economic cost of diabetes can be catastrophic for both the individual and society. He notes that monthly insulin treatment, which is a question of life and death for many patients, can be expensive. “We know that just the annual direct medical costs exceed $827 billion every year," said Krug. "It is a very, very vast, large number and that is not taking into account many other types of costs such as lost productivity, etc., etc…”
Promoting healthy eating habits
The U.N. agency says adopting a healthy lifestyle can prevent the majority of cases. The report’s recommendations include eating healthier, engaging in more physical activity and avoiding excessive weight gain.
WHO Calls on Governments to Combat Global Diabetes Surge
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.
FDA staff question utility, trials of Novo Nordisk diabetes drug
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." (FDA modernizes Nutrition Facts label for packaged foods) "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.
FDA targets sugar in new labeling rules
