A deal between the manufacturer and Sanofi-Aventis should make Afrezza available in the United States next year. The novel inhaled insulin product, Afrezza, recently approved for use in the United States, will be launched there at the beginning of next year following a commercial agreement signed between the manufacturer, MannKind, and pharmaceutical giant Sanofi.
The 2 companies announced the deal today, which sees Sanofi granted an exclusive worldwide license to develop and commercialize Afrezza, a rapid-acting human insulin powder for inhalation, for the treatment of adults with type 1 or type 2 diabetes. ...
Because it's inhaled, it's absorbed more quickly and in a different way.
"Afrezza is rapidly absorbed from the cells in the lungs [to the bloodstream]," says R. Keith Campbell, RPh. He's a certified diabetes educator and distinguished professor emeritus in diabetes care and pharmacotherapy at Washington State University College of Pharmacy. He has studied the drug but has no ties to its developer.
"From the time you inhale it to the time it actually peaks [in the blood] is 15 to 20 minutes," Campbell says. Injected insulin taken before a meal, he says, takes about an hour to peak.
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Find out in our 2014 Residents Salary and Debt Report > The body also clears Afrezza more quickly than insulin injected at mealtime, says Bruce Bode, MD. He's a diabetes specialist in Atlanta who did a clinical trial funded by MannKind.
Besides its rapid peak, the drug is ''pretty much gone in 2 or 3 hours," Bode says. Rapid-acting injected insulins, he says, usually ''hang around for about 4 hours. Afrezza is fast in, fast out. It is emulating , in essence, what the pancreas does."
How is it taken?
Users place a dose of Afrezza, in powder form, into a small, whistle-sized inhaler. Doses come in a cartridge, and each cartridge contains a single dose.
How does Afrezza work compared with rapid-acting injected insulins?
In a 24-week study, Bode compared Afrezza with a rapid-acting, injected insulin in more than 500 patients with type 1 diabetes. Afrezza and injected insulin controlled blood sugar equally well, he says. But he found that those using Afrezza were less likely to get very low blood sugar, a complication of insulin use.
With Afrezza, "there is also less weight gain," Bode says. He credits that to the shorter time Afrezza remains in the body.
In another study, researchers found that people with type 2 diabetes who weren't getting enough control of with oral medications did better when they added inhaled insulin before meals.
Both studies were presented at the American Diabetes Association (ADA) 2014 Scientific Sessions last month.
The FDA approved Afrezza's safety and effectiveness based on about 3000 people, including 1000 with type 1 diabetes and about 2000 with type 2.
What about side effects?
In the Afrezza clinical trials, the most commonly reported side effects were low blood sugar, cough, and throat pain or irritation, according to the FDA. The drug will carry a warning that it could cause sudden tightening of the chest, known as acute bronchospasm.
What will it cost?
"Our expectation is it should be priced comparably to current fast-acting [injected] insulins delivered in pen form," says Matthew Pfeffer, a MannKind spokesperson.
Prices for the fast-acting insulin pens vary. One popular fast-acting pen insulin costs about $270 a month, without insurance coverage, for a person who needs 30 units a day, a common amount.
When will it be available?
That is not certain. MannKind is seeking to partner with a pharmaceutical company for distribution, Pfeffer says.
