Los Angeles billionaire inventor Alfred Mann’s almost decade-long quest to develop an inhalable form of insulin for diabetics won approval Friday from U.S. regulators.
His Valencia company, MannKind Corp., got the OK to sell the drug called Afrezza, although regulators warned the product shouldn’t be used by diabetics with asthma or a serious lung disease. The Food and Drug Administration said Friday it had cleared Afrezza for Type 1 and Type 2 diabetes.
The drug labeling will warn that spasms in the airways of the lung have been seen in patients with asthma and chronic obstructive pulmonary disease and will advise against smokers using the medicine, the agency said in a statement.
Mann and his firm spent more than $2 billion bringing the drug to market, and it took almost eight years seeking approval of the diabetes therapy since starting late-stage clinical trials.
MannKind’s share price has ranged from a high of $21.70 to a low of $1.60 as Pfizer Inc. pulled the only inhaled insulin from the market and the FDA twice rejected MannKind’s therapy, most recently in 2011, after the company switched inhalers during the review process.
“Afrezza is a new treatment option for patients with diabetes requiring mealtime insulin,” Jean-Marc Guettier, a medical doctor and director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research, said in a statement.
“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.”
The FDA said the drug’s effectiveness was tested in more than 3,000 patients. Patients with Type 1 Diabetes should not use Afrezza as a replacement for long-acting insulin, the statement said.