In Diabetes Today
FDA Panel Endorses New Diabetes
Pill
Low-dose Insulin Doesn't Affect Kids' Growth
What is Pancreatic
Islet Transplantation?
In Diabetes Today
FDA Panel Endorses New Diabetes Pill
WASHINGTON - A day after recommending the first inhaled form of insulin to treat diabetes, a Food and Drug Administration advisory panel on Friday endorsed a new pill that helps control blood sugar levels as well as cholesterol in people with the most common form of the condition.
The drug, muraglitazar, will be marketed under the name Pargluva. It was developed by Bristol-Myers Squibb and Merck & Co. A joint statement from the companies said they would conduct extensive monitoring of people using the drug to ensure it causes no long-term problems.
The non-insulin treatment is designed for people with Type 2 diabetes, the most common form of the condition that occurs most often in adults who are overweight.
Members of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 8-1 to recommend FDA approval of the drug to treat Type II diabetes when used alone. It voted 7-2 to endorse its use alongside metformin, another treatment.
However, the panel voted 6-3 against recommending its use in combination with a sulfonylurea, still another drug that prompts the pancreas to release more natural insulin into the bloodstream.
The FDA usually follows the advice of its committees but is not required to do so. On Thursday, the committee endorsed the first inhalable insulin for diabetics.
Documents released by the FDA this week raised concerns that muraglitazar may increase the risk to people with heart problems. In studies, a few more people taking the drug died of heart failure or suffered serious heart problems than those taking placebos or undergoing other treatments. However, it was unclear to the FDA whether that effect was directly related to the drug or the result of another factor.
The advocacy group Public Citizen said in a statement Friday that the drug was too risky to approve because of this and other issues.
About 18 million people in the United States are thought to have diabetes, although many do not know it. Untreated diabetes can lead to blindness, loss of limb function, or death.
In Diabetes Today
FDA Panel Approves Exubera
Sep. 9--Nearly two decades after John Patton began work to create a form of insulin that can be inhaled so diabetics wouldn't have to endure needle injections, the San Carlos company he co-founded -- Nektar Therapeutics -- has won a key recommendation for approval to put the drug on the market.
A U.S. Food and Drug Administration panel Thursday voted 7-2 to advise the agency to approve the drug Exubera, which Nektar developed in conjunction with pharmaceutical giants Pfizer and Sanofi-Aventis. The FDA generally follows the advice of such advisory groups.
That was tremendous news for the 750 employees at Nektar, especially Patton, a board member who also is the company's chief scientific officer.
"This is awesome," said Patton, 58, who helped found Nektar in 1990, when it was known as Inhale Therapeutic Systems. "I've been working on this for 19 years. The company has been working on it for 15 years. This is the validation of years and years of hard work. This is huge for us."
Considering how many diabetics would love to find a less painful way to take insulin, he added, "This has a chance to be one of the biggest biotechnology products to come out of the Bay Area."
More than 18 million people in the United States -- 6.3 percent of the population -- suffer from diabetes, which prevents the body from producing or properly using insulin, a hormone needed to convert sugar, starches and other food into energy.
Patton said he and his co-founder, Robert Platz, had long wanted to come up with a version that could be inhaled. But a number of technical hurdles had to be overcome.
For one thing, the powder had to be extremely fine so it could be inhaled, and in a form that wouldn't need to be refrigerated. They also wanted it to dissolve easily in the fluid of the lungs, so it could be quickly absorbed by the blood. And they needed to develop equipment to accompany it, including a portable, easy-to-use inhaler.
Patton declined to say how much Nektar executives expect to make from the drug if it is approved by the FDA. But he said analysts have estimated it could produce annual sales of $1 billion to $10 billion.
Concerns were expressed during the panel's meeting about use of Exubera by people with lung disease or those exposed to second-hand cigarette smoke. Tests of the drug have shown that chronic smokers tend to absorb more insulin than non-smokers. That could result in a higher risk of hypoglycaemia, which can cause dizziness and blackouts.
Pfizer executives at the Thursday meeting said the product's label would warn smokers against using the product.
Studies also showed people taking the inhaled insulin had more cases of severe asthma. Pfizer executives said Thursday that they would monitor people taking the drug after it is approved for sale.
Paul Woolf, the committee chairman, who is head of the department of medicine at Crozer Chester Medical Centre in Upland, Pa., voted not to recommend Exubera. So did James Stoller, head of respiratory therapy at the Cleveland Clinic's pulmonary and critical care medicine division.
Bloomberg News Service contributed to this report.
In Diabetes Today
Low-dose Insulin Doesn't Affect Kids'
Growth
NEW YORK (Reuters Health) - Data from a diabetes prevention trial show that low-dose insulin treatment has no apparent effect on body weight or physical development in adolescents and children who are at increased risk of developing diabetes type 1.
"The role of insulin in body weight regulation has been the subject of much debate," senior investigator Dr. David S. Ludwig told Reuters Health. "Some experts argue that insulin acts in the brain to decrease hunger and food intake. Others propose that insulin acts in the periphery to promote fat deposition."
To look into this question further, Ludwig of Children's Hospital Boston and colleagues analysed data from a trial of low-dose insulin aimed at preventing the development of type 1 diabetes in those at risk.
As reported in the medical journal Diabetes Care, the team focused on 55 young subjects who underwent insulin therapy and 45 who were just closely monitored. At the start of the study, the participants ranged in age from 4 to almost 19 years.
Over the course of two years, there were no differences between the groups in physical development. In particular, there were no differences in average weight, body mass index or height between children on low-dose insulin and those who were untreated.
Ludwig concluded: "The results of our study indicate that insulin at low doses in children causes neither weight gain nor weight loss, possibly because central and peripheral actions are closely counter- balanced."
He added that further research is needed "to determine whether insulin, or agents that block insulin action, could play a role in body weight management."
SOURCE: Diabetes Care, August 2005.
2005 Reuters Health