FDA Advisers Back New Inhaled Insulin — Physician’s First Watch
FDA Advisers Back New Inhaled Insulin
By Kelly Young
An advisory committee to the FDA has voted to recommend approval of Afrezza, a new inhaled form of insulin for types 1 and 2 diabetes, the New York Times reports.
The Times says that the votes were surprising, given the FDA's own critical review of the drug. In clinical trials, lung cancer diagnoses were more common among patients receiving Afrezza than in the comparator group, but the absolute numbers were small.
Pfizer's inhaled insulin drug, Exubera, which was pulled from the market in 2007 for low sales, also carried an increased lung cancer risk. The Exubera inhaler was roughly the size of a tennis ball can. The Afrezza inhaler, meanwhile, can fit in the palm of the hand.
MannKind, which developed Afrezza, says that its insulin takes effect faster than rapid-acting injected insulin. The FDA could decide whether to approve the drug by the middle of April.