NYT: F.D.A. Panel Endorses Inhaled Form of Insulin

[DeepModem Mom]

F.D.A. Panel Endorses Inhaled Form of Insulin
By ANDREW POLLACK
Published: September 9, 2005


The first inhaled form of insulin, a product that could reduce or eliminate the daily injections needed by millions of diabetics, moved closer to federal approval yesterday.

An advisory panel to the Food and Drug Administration voted 7 to 2 to recommend approval of the drug for adults with either Type 1 or Type 2 diabetes, despite some concerns about the long-term effect that inhaling insulin would have on users' lungs.

The product, called Exubera, was developed by Pfizer in partnership with Sanofi-Aventis of France and Nektar Therapeutics, a California biotechnology firm.

The full F.D.A., sensitive to criticism in the last year that it has been lax on drug safety, is still to rule on approval. The agency often, but not always, follows the advice of its advisory committees, which are made up of outside experts.

Because Exubera is a novel product that would be taken for years, it is conceivable the F.D.A. would ask for more data before approval, especially given the questions about its effect on the lungs and the fact that Exubera's advantage over injected insulin is mostly convenience. Data presented by Pfizer showed that Exubera was equivalent to injected insulin in controlling blood sugar, but not superior....


http://www.nytimes.com/2005/09/09/business/09drug.html