WASHINGTON, June 27 The U.S. Food and Drug Administration said on Friday it has approved MannKind Corp's inhaled insulin device, Afrezza, capping an arduous journey for the company and its octogenarian founder, Alfred Mann.
The FDA said the device offers a new treatment option for patients with Type 1 diabetes.
"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," Dr. Jean-Marc Guettier, director of the FDA's endocrinology division, said in a statement.
The drug will carry a boxed warning, the most serious available, that acute bronchospasm has been seen in patients with asthma and chronic obstructive pulmonary disease and that it should not be used in patients with those conditions. (Reporting by Toni Clarke; Editing by Sandra Maler)