FDA Delays Decision on Inhalable Insulin

The Food and Drug Administration has decided to delay their decision on Afrezza, a type of inhalable insulin designed to treat diabetics, by three months, buying themselves more time to consider the safety and effectiveness of the drug.

Last week a United States Food and Drug Administration (FDA) advisory committee recommended the drug Afrezza and its associated devices for approval.

Afrezza, developed by MannKind Corp., is a "powdered" insulin designed for inhalation via an inhaler device. According to the drug's producer, Afrezza is a "rapid-acting" form of insulin delivery that reportedly takes a much faster effect on a diabetic's body than the leading injected insulin. Results from multiple clinical trials have shown that this is at least partially true, with the drug proving "rapid-acting" but not as effective-per-dose as its liquid counterparts -- traditionally delivered through automated insulin pumps or injection.

While Afrezza has been pending FDA approval since 2009, regulators and advisory committees alike have been hesitant about letting the drug into the U.S. market as initial trial results revealed a small chance that the drug could be associated with an increased risk of lung cancer.

However, according to the FDA advisory committee's acting chairman, Dr. Robert Smith, the results of a recent FDA investigation had quelled many concerns. According to a post-investigation report, the small number of Afrezza trial participants -- out of thousands -- who later developed lung cancer just as likely developed the cancer from unrelated and natural causes as they did from adverse effects of the drug.

This revelation prompted the advisory committee to suggest approval for the drug as it offers an alternative form of treatment for diabetics who "are not effectively served by currently available insulin."

The FDA, who has the final say about the drug's approval, was slated to come to a decision about Afrezza later this month, on April 15. However, the FDA is now announcing that the decision will be delayed by three months, with the decision finally being made on July 15.

The delay is reportedly occurring  "in order to provide time for a full review of information submitted by MannKind in response to the FDA's requests," according to a MannKind press release.

The press release was published on April 7.

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