Diabetes Type 1 and Type 2 Treatment Product 2014: FDA Approves Inhaled Insulin Drug by Mannkind
American adults with Types 1 or 2 diabetes will soon have another option for treatment. On Friday, the Food and Drug Administration approved a form of insulin that is inhaled instead of injected, The New York Times reported.
The drug is called Afrezza, and it was developed by MannKind Corp., which is headed by billionaire Alfred E. Mann, according to the Times.
"Today's FDA action validates the years of clinical research and commitment that powered the development of this unique treatment," Mann said in a statement.
While FDA approval is a milestone for the company, the treatment isn't new. The Times reports that drugmaker Pfizer developed an inhaled insulin treatment called Exubra that was a huge flop and was taken off the market.
MannKind also is challenged with finding a company to sell Afrezza, but CFO Matthew Pfeffer told The Times that FDA approval will help. The company has said over the years that it was in discussions with potential partners.
Pfeffer also said he's confident Afrezza won't meet the same end as Exubra, claiming it uses different technology. It won't hurt that the Afrezza inhaler is the size of a referee's whistle, and the Exubra inhaler was as big as a tennis ball can, according to The Times.
The drug is designed to be used as a fast-acting insulin treatment, taken at meal times, Bloomberg reported, adding that Afrezza isn't for those who have asthma or chronic obstructive pulmonary disease.
Afrezza is a powder, delivered through a cartridge, and is designed to control blood sugar during meal times in less time than standard injections. The FDA said it doesn't replace long-acting insulin for Type 1 patients, whose bodies don't produce insulin.
MannKind had been working on the drug for the better part of the last decade and had been rejected twice by the FDA, according to Bloomberg.
An estimated 25.8 million Americans have diabetes, a condition in which the body doesn't naturally produce or use insulin effectively to break down sugar in the blood, the Bloomberg report said. Diabetes can lead to heart disease, blindness, and nerve and kidney damage.
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