Afrezza, a New Inhaled Insulin, Is Approved by FDA

The Food and Drug Administration on Friday approved a form of insulin that is inhaled rather than injected, providing a new option for millions of Americans with diabetes.

The approval of the drug, Afrezza, is a milestone in a long and expensive journey for its developer, MannKind Corporation, and for its chief executive, Alfred E. Mann, an 88-year-old billionaire who spent a big part of his fortune sustaining the company through various setbacks.

'Today's F.D.A. action validates the years of clinical research and commitment that powered the development of this unique therapy,' Mr. Mann said in a statement Friday.

But MannKind still faces the challenge of selling the drug, which was approved for adults with either Type 1 or Type 2 diabetes.

An earlier inhaled insulin, Pfizer's Exubera, flopped miserably and was withdrawn from the market. MannKind also has not signed up a larger pharmaceutical company to help market Afrezza, even though it has said for years that it was in discussions with potential partners.

The approval 'is obviously going to help that process,' Matthew J. Pfeffer, the company's chief financial officer, said in an interview on Friday, adding that Afrezza would not be available to patients until a partner was ready.

He also said Afrezza would have a better chance of success than Exubera because 'it's a very different product, very much a next-generation product.' The inhaler for Afrezza is about the size of a referee's whistle while Exubera's was the size of a tennis ball can.

Taking a puff of Afrezza at the beginning of a meal could be less painful and more convenient for many patients than an injection. But some doctors worry about the long-term safety of delivering insulin through the lungs.

The prescribing information for Afrezza calls for lung function to be tested before patients start on the drug and periodically thereafter. The label also has a boxed warning, the strongest kind, that Afrezza should not be used by people with asthma or other chronic lung diseases because of the risk of bronchospasms. It is also not recommended for smokers or recent smokers.

MannKind has also agreed to conduct a long-term study to assess whether Afrezza raises the risk of lung cancer or impairs lung function.

The company, based in Valencia, Calif., has lost more than $2.3 billion since its inception. The inhaled insulin was rejected twice by the F.D.A., forcing MannKind to conduct new clinical trials.

But the approval this time was not a surprise because an advisory committee to the F.D.A. had endorsed the drug in April. MannKind shares initially plunged when the approval was announced in the last hour of regular trading but recovered in after-hours trading.

Mr. Mann has spent more than $900 million sustaining MannKind through its travails, an investment that for a long time was losing money. But now his roughly 40 percent stake in the company is worth around $1.6 billion.

Mr. Mann made his fortune starting aerospace and medical device companies, including MiniMed, a maker of insulin pumps for diabetics that was sold to Medtronic for about $3 billion.

Another question is how Afrezza compares with injected mealtime insulin. In the clinical trial for Type 1 diabetes, Afrezza provided less reduction in blood sugar than injected insulin, but the results were close enough that trial was deemed a success.