Washington – A government advisory panel is set to consider the first insulin that can be inhaled rather than injected, a novel approach to keeping diabetics’ blood sugar under control without needles.
The insulin, called Exubera by its manufacturer, is pitched as a huge improvement in the quality of life for diabetics, one that could persuade some who won’t take injections to use insulin more regularly. The insulin is being developed by Pfizer, Sanofi-Aventis and Nektar Therapeutics.
According to documents released Wednesday by the Food and Drug Administration, concerns about inhaled insulin center on its long-term effects on the lungs and whether it is effective and safe for smokers, children and patients with lung disease.
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will meet today to consider whether to recommend the drug to government regulators for approval. The FDA usually follows the recommendations of its advisory committees, but it isn’t required to.
More than 18 million people in the U.S. are estimated to have diabetes, although some do not know it. Most have Type 2, a condition linked to obesity that occurs when the body cannot effectively use the insulin it makes. Sometimes this can be treated with pills instead of injections.
