-- E.J. Mundell
SATURDAY, June 28, 2014 (HealthDay News) -- People with type 1
or 2 diabetes now have a new means of getting their medication,
with the U.S. Food and Drug Administration's approval on Friday of
the first inhaled medicine for the blood sugar disease.
The drug, Afrezza, "is a new treatment option for patients with
diabetes requiring mealtime insulin," Dr. Jean-Marc Guettier,
director of the Division of Metabolism and Endocrinology Products
in the FDA's Center for Drug Evaluation and Research, said in an
agency news release on Friday.
He said that Afrezza's approval "broadens the options available
for delivering mealtime insulin in the overall management of
patients with diabetes who require it to control blood sugar
Diabetes falls into two main categories: type 1, an autoimmune
illness which is often inherited and involves a dysfunction of
insulin-producing cells in the pancreas; and type 2, which develops
over time and is tied closely to obesity. Between 90 percent and 95
percent of diabetes cases are of the type 2 variety, according to
the U.S. National Institutes of Health.
The FDA estimates that almost 26 million Americans -- about 8.3
percent of the population -- now live with diabetes, which can lead
to dangerous complications such as heart disease, vision loss and
nerve and kidney problems. Many patients must take injected insulin
daily to maintain healthy blood sugar levels.
Afrezza's approval came after a study involving more than 3,000
people -- approximately 1,000 with type 1 diabetes and nearly 2,000
with the type 2 form of the illness.
For people with type 1 disease, researchers compared the
effectiveness of Afrezza in adult patients against that of
fast-acting insulin (aspart), used in both cases alongside basal
insulin (long-acting insulin). Over 6 months, the combo of
long-acting insulin and Afrezza met required treatment
effectiveness in terms of blood sugar control, the FDA said.
For patients with type 2 diabetes, researchers combined Afrezza
with standard diabetes pills and compared the use of the inhaled
drug at mealtimes against the use of standard medications plus a
placebo. At six months, the Afrezza-plus-standard medications
combination produced better results overall, the FDA said.
The agency stressed that Afrezza should never substitute for
long-acting insulin, and patients with type 1 diabetes must use the
drug in combination with long-acting insulin. Smokers should avoid
Afrezza, as well, the agency said, and the drug is not to be used
in the treatment of a condition called diabetic ketoacidosis.
People with certain lung conditions should also not use Afrezza,
due to a dangerous complication called acute bronchospasm. For this
reason, the FDA has ordered a warning be placed on the product's
labeling to caution people with chronic obstructive pulmonary
disease (COPD) from using the drug. The FDA is also advising that
people with asthma avoid Afrezza for the same reason.
According to the agency, the most common side effects from
Afrezza were hypoglycemia (low blood sugar), cough, and throat pain
The FDA is also ordering that "post-marketing studies" be
conducted to track the safety and effectiveness of Afrezza in
children, and to see if there is any connection between the use of
Afrezza and any lung cancers.
Afrezza is manufactured by MannKind Corporation of Danbury,
For more on type 1 and type 2 diabetes, head to the
American Diabetes Association.
Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.
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