A government advisory panel backed approval of an insulin inhaler for the first time potentially offering adult diabetics an alternative to injections for controlling their blood sugar.
Experts recommended Food and Drug Administration approval of the drug by a 7 to 2 vote, despite what many said were serious concerns about its long-term safety and ease of use by patients.
If approved, the drug, known as Exubera, would represent the first major shift away from needles and syringes for millions of diabetics who must take daily injections to control glucose. The product works much like inhalers already used by asthma and allergy sufferers, by producing an insulin-powder cloud inhaled via a handheld plastic machine.
Pharma companies have long sought to offer diabetics a way to take what for many patients amounts to multiple daily insulin doses without painful needle sticks. The drug has been in development for a decade and is now backed by a joint venture between Pfizer, Sanofi-Aventis and Nektar Therapeutics.