* Glucose control similar to standard insulin
* Small differences in lung function observed
* Lung changes disappeared 3 mos after stopping Afrezza
LOS ANGELES, April 23 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
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
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
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
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, 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)