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MannKind says Afrezza safe and effective in trials
10:00 am ET 04/23/2010- Reuters
* Glucose control similar to standard insulin
* Small differences in lung function observed
* Lung changes disappeared 3 mos after stopping Afrezza
LOS ANGELES, April 23 (Reuters) - MannKind Corp <MNKD.O> said on Friday data shows that its experimental inhaled insulin device, Afrezza, controls blood sugar levels in patients with diabetes without meaningful, long-term changes in lung function.
The company has filed for U.S. Food and Drug Administration approval of Afrezza, which is designed to deliver a more effective rapid-acting insulin than injectable products. The FDA said in March that it needed more information on the MannKind drug device before it could complete its review.
Results from two Phase III studies of Afrezza were presented in Boston at a meeting of the American Association of Clinical Endocrinologists.
MannKind said a two-year trial in patients with Type 1, also known as juvenile, diabetes found that Afrezza provided glucose control similar to standard insulin therapy along with weight loss and reduced incidence of hypoglycemia.
After two years, levels of HbA1c, a common measure of blood sugar, were down 0.29 percent in the Afrezza group and 0.31 percent in the group receiving usual care. Afrezza resulted in average weight loss of 0.59 kilogram vs. weight gain of 1.38 kg for patients on standard care.
The incidence of hypoglycemic events in the Afrezza group was 61.8 percent, compared with 66.05 percent for the usual care group. There were 2.36 severe events per 100 subject-months in the Afrezza group compared with 3.76 for the usual diabetes care group.
Another 649-patient study looking at follow-up safety data suggests "that the pattern and magnitude of changes in lung function associated with the use of Afrezza in patients with Type 1 and Type 2 diabetes are not likely due to any structural alterations in the lungs and are not clinically meaningful," the company said in a statement.
The findings were based on changes in pulmonary function after patients stopped use of Afrezza and resumed usual treatment.
Adults with diabetes who participated in any of four clinical trials of Afrezza were invited to participate in the safety trial, which followed them for up to three months. Lung function was assessed at the end of the parent trial and one and three months after completion of the parent trial.
During the original trials, "small, nonprogressive differences" in forced expiratory volume in one second and carbon monoxide diffusing capacity were observed in the Afrezza group.
MannKind said the changes disappeared, regardless of the duration of exposure to Afrezza, when the groups were compared three months after patients resumed usual therapy.
In the United States, about 11 percent of adults have diabetes. Most have Type 2 diabetes, the kind closely linked to obesity. Type 1 diabetes is an autoimmune disease in which the body mistakenly destroys the cells in the pancreas that make insulin.
Insulin, a hormone produced by the pancreas, normally regulates the body's glucose levels. Without proper levels of the hormone, the body becomes unable to break down and use sugar. If untreated, blood vessels and nerves are destroyed, organs fail and patients can die. (Reporting by Deena Beasley, editing by Matthew Lewis)
