News

Posted On: 11/03/2005

Inhalable Exuberance on the Horizon

PharmaManufacturing.com

By Paul Thomas, Managing Editor

An FDA advisory panel recently recommended that the Agency approve Pfizer’s Exubera, which would make it the first inhaled insulin drug to hit the market. Exubera was developed in collaboration with Nektar Therapeutics and Sanofi-Aventis.

Meanwhile, Eli Lilly announced that it has completed Phase II trials of the inhalable insulin product it is developing with Alkermes, Inc. Phase III trials are under way.

Pressure on FDA from the American Diabetes Association for an alternative to needle injections accelerated Exubera’s journey, says insulin-delivery watcher Bill Martineau, analyst with The Freedonia Group (Cleveland), who had expected that approval would not come until 2007 (Pharmaceutical Manufacturing, March 2005, p. 10). Recommendations by the advisory committee are usually heeded by FDA, meaning approval may come early in 2006.

Nevertheless, in late October, FDA stated its intentions to extend its review period by three months, to review additional technical information submitted by the manufacturers.

Even if approved, Exubera will continute to face strict regulatory scrutiny, Martineau believes, because it has been linked to short-term respiratory problems in users. In clinical studies, patients experienced a small decrease in lung capacity in the first few weeks of treatment.

If Exubera goes on the market, and stays, it will do quite well in the more than $850 million segment for short-acting insulin, Martineau says.