MannKind seeks FDA approval for inhaled insulin

MannKind is determined to push into the commercial market for inhaled insulin--an ambitious move that Pfizer has already tried and failed. Yesterday MannKind announced that it had filed for FDA approval to market Afresa, an inhaled insulin--designed to control hyperglycemia--that is likely to become the company's first commercial product.

"We are delighted to have reached this important milestone," said CEO Alfred Mann in a statement. "This submission is the culmination of years of clinical research that has supported our long-held belief that Afresa will be a first-in-class ultra rapid-acting insulin with the potential to change the way diabetes is treated."

Anemic sales and safety issues convinced Pfizer to drop its efforts to market an inhaled insulin product last year. And last week Pfizer sold its German insulin factory to MannKind. But Mann insists that Afresa is a better product than the one that failed at Pfizer. And the company has steadfastly pushed ahead as others bowed out. 23.6 million people in the United States, or 8 percent of the population, have diabetes.

- here's MannKind's release
- read the story in the Los Angeles Business Journal

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