FDA approves inhaled diabetes medication

June 28, 2014
FDA approves inhaled diabetes medication
Afrezza is taken at mealtimes, along with long-acting insulin or standard diabetes pills.

(HealthDay)—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 ."

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 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 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 ), cough, and throat pain or irritation.

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, Conn.

Explore further: FDA approves new type 2 diabetes drug

More information: For more on type 1 and type 2 diabetes, head to the American Diabetes Association.

Related Stories

FDA approves new type 2 diabetes drug

April 15, 2014
(HealthDay)—Millions of Americans with type 2 diabetes have a new treatment option with the U.S. Food and Drug Administration's approval Tuesday of a once-weekly injectable drug, Tanzeum.

Modified iPhone shows promise against type 1 diabetes

June 16, 2014
A device that uses a modified iPhone to help regulate the blood sugar of people with type 1 diabetes appears to work better than an insulin pump, researchers say.

US approves diabetes drug with new approach (Update)

January 8, 2014
The U.S. Food and Drug Administration on Wednesday approved a new diabetes drug from Bristol-Myers Squibb and AstraZeneca that uses a novel approach to reduce blood sugar.

FDA approves 3 new drugs for type 2 diabetes

January 26, 2013
(HealthDay)—The U.S. Food and Drug Administration late Friday approved three new medications to help people battle type 2 diabetes.

Study reverses current thought on treatment of cirrhosis

June 19, 2014
Researchers at Mayo Clinic released a new study reversing current thought on the treatment of cirrhotic patients with type 2 diabetes. The study found that the continuation of metformin after a cirrhosis diagnosis improved ...

Recommended for you

Diabetes can be tracked with our Google searches

July 26, 2017
The emergence of Type 2 Diabetes could be more effectively monitored using our Google searches—helping public health officials keep track of the disease and halt its spread—according to research by the University of Warwick.

Scientists discover a new way to treat type 2 diabetes

July 21, 2017
Medication currently being used to treat obesity is also proving to have significant health benefits for patients with type 2 diabetes. A new study published today in Molecular Metabolism explains how this therapeutic benefit ...

Alzheimer's drug cuts hallmark inflammation related to metabolic syndrome by 25 percent

July 20, 2017
An existing Alzheimer's medication slashes inflammation and insulin resistance in patients with metabolic syndrome, a potential therapeutic intervention for a highly dangerous condition affecting 30 percent of adults in the ...

Diabetes or its precursor affects 100 million Americans

July 19, 2017
Almost one-third of the US population—100 million people—either has diabetes or its precursor condition, known as pre-diabetes, said a government report Tuesday.

One virus may protect against type 1 diabetes, others may increase risk

July 11, 2017
Doctors can't predict who will develop type 1 diabetes, a chronic autoimmune disease in which the immune system destroys the cells needed to control blood-sugar levels, requiring daily insulin injections and continual monitoring.

Diabetes complications are a risk factor for repeat hospitalizations, study shows

July 7, 2017
For patients with diabetes, one reason for hospitalization and unplanned hospital readmission is severe dysglycemia (uncontrolled hyperglycemia - high blood sugar, or hypoglycemia - low blood sugar), says new research published ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.