Pfizer and two partners received approval from a scientific advisory panel Thursday for an inhaled form of insulin, staying ahead of Eli Lilly and Co. and others in the race to market an alternative to injections that could generate $1 billion in annual sales.
The recommendation by a Food and Drug Administration advisory panel came despite questions about use of the inhalable drug by people who have lung disease or have been exposed to secondhand smoke.
No specific restrictions were recommended for Exubera, but FDA officials said smokers probably would not be able to use the drug. Their blood sugar could fall dangerously low with Exubera because they absorb much more inhaled insulin in their lungs than do nonsmokers.
Some advisers also were concerned that patients might not use the device properly. Drug company representatives suggest that the inhaler is no more complicated than the injections many diabetics now must rely on.
Panel members twice voted 7-2 to recommend FDA approval of Exubera for each of the two most common forms of diabetes. Developers are Pfizer, Sanofi-Aventis and Nektar Therapeutics.
The FDA usually follows the recommendations of its advisory committees, but is not required to do so.
Pfizer and its partners lead what essentially is a three-way race to get an inhalable insulin on the market. An inhalable product should generate sales of $1 billion or more a year, according to drug stock analysts.
Other inhalable insulins are still in human testing. One is from Indianapolis-based Lilly and Alkermes Inc., and another is under development by the Danish firm Novo Nordisk and Aradigm.
Lilly, the U.S. leader in insulin sales, probably won’t get its inhalable insulin to market before 2008, say drug industry analysts. Lilly and Alkermes still must put its inhalable insulin through extensive final-phase tests, which began this summer, said Lilly spokesman Jamaison Schuler.
Even though Lilly and Alkermes are behind in the race to market, “We are optimistic about our device,” Schuler said. “We believe size and simplicity are really going to matter.”
The Lilly-Alkermes inhaler is small enough to fit in the palm of the hand and is breath-activated, unlike Exubera, a larger device that relies on compressed air to operate.
The FDA advisers questioned the developers of Exubera about the long-term effects of distributing insulin to the body through the lungs, rather than directly into the bloodstream.
The companies, which are promoting Exubera as an easier-to-take alternative, propose to conduct studies on the long-term effects of the drug until 2019.
During trials, researchers found that inhaled insulin generally was as effective as injections in controlling blood-sugar levels. Some patients who took inhaled insulin complained of coughing and a small decrease in breathing capacity.
It is estimated that more than 18 million people in the U.S. have diabetes, although some do not know it. The number of people with diabetes is believed to have tripled in the past quarter- century.