MannKind Corp. said it has filed for U.S. Food and Drug Administration approval to market Afresa, its inhaled insulin product for diabetics.
The Valencia biotech said it submitted a new drug application for the use of Afresa in adults. The drug, which would be MannKind's first commercial product, is intended to control hyperglycemia, or high blood sugar levels.
If approved, MannKind would have the only inhaled insulin product on the market. Pfizer Inc., which last week agreed to sell the company its insulin factory in Germany, abandoned its own insulin inhaler last year due to poor sales and safety concerns. Company founder Alfred Mann has argued that his innovative inhaler is safer than Pfizer's and has therapeutic advantages over injected insulin.
"We are delighted to have reached this important milestone," Mann, the company's chairman and chief executive, said 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."
FDA reviews for new drugs typically take at least 10 months, but could take longer given the problems with Pfizer's Exubera. Post-approval studies showed the drug increased cancer risks for patients who had been smokers.
MannKind shares closed up 4 cents or 1 percent to $3.10 on the Nasdaq.
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