Could this be the end of daily insulin shots for some of the nearly 25.8 million people in the United States — 8.3 percent of the population — who suffer from diabetes?
The medicine is meant be used at the beginning of a meal or within 20 minutes after the start of a meal to control glycemic levels in adults with diabetes.
“Afrezza is a new treatment option for patients with diabetes requiring mealtime insulin,” said Dr. Jean-Marc Guettier, director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “Today’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 levels.”
This is the third time the maker of Afrezza, MannKind Corporation out of Danbury, Connecticut, has tried to seek FDA approval for the drug. The company conducted additional safety studies after the first two attempts failed.
During the approval process, the drug was tested in 3,017 patients, 1,026 with type 1 diabetes and 1,991 with type 2.
“Today’s FDA action validates the years of clinical research and commitment that powered the development of this unique therapy,” said company founder Alfred Mann in a statement. “(Afrazza) has the potential to change the way that diabetes is treated.”
— Juan J. Gutiérrez (@JJGAlonso) June 27, 2014
The FDA said Afrezza is not a substitute for long-acting insulin and must be used in combination with long-acting insulin for patients with type 1 diabetes and with oral medication for people with type 2 diabetes.
Afrezza has a warning that it may cause “a sudden tightening of the chest.” It is not recommended for people with asthma or COPD. It also shouldn’t be used to treat diabetec ketoacidosis or by patients who smoke.
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