Inhaled insulin Afrezza backed by FDA advisors in the US

Thu, 03 Apr 2014
A new form of inhaled insulin, called Afrezza, has received backing from a panel of advisors for the Food and Drug Administration (FDA) in the USA.

People with needle phobia or otherwise reluctant to take injections of insulin daily will be encouraged by the news.

The advisors unanimously voted for approval for use in people with type 2 diabetes and voted 13 to 1 in favour of its use in adults with type 1 diabetes. The one advisor that voted against backing noted that there were still questions over whether lung cancer may be a risk and that the inhaled insulin was not as effective as injected insulin.

The backing is important for the FDA to approve the use of the insulin in the US. If approved in the US, the makers, MannKind Corp, will file for approval within Europe.

Afrezza has shown no evidence of a negative effect on the lungs in clinical studies and the question over lung cancer dates back to a previous inhaled insulin product Exubera. In Exubera's post approval clinical trials, one in 1,000 (6 out 4,740) had developed lung cancer. It is not known, however, whether Exubera was a factor in those cases or not.

Exubera disappeared from the market before 2010. Whilst there were unanswered question about lung safety, the large size and inconvenience of the inhaler was arguably the biggest factor in the product's failure. Thankfully, Afrezza does not have those size issues with the device being smaller than most diabetes lancing devices.
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