Exubera Lung Cancer Warning Could be Death Knell for Inhaled InsulinApr 10, 2008 | Parker Waichman LLP
Exubera Inhalation Powder, an inhaled insulin product, has been linked to the development of lung cancer, Pfizer, Inc. warned late yesterday. As a result, Pfizer is updating the Exubera label to include a warning about the lung cancer risk. The revelations about lung cancer have led some to speculate that the concept of an inhaled insulin could now be all but dead.
Exubera was brought to market by Pfizer in 2006, and was the first inhaled insulin product on the market. But in October 2007 - barely a year after it appeared - Pfizer announced it would stop marketing Exubera because of low demand. Though it worked as well as injectable insulin, Exubera was much more expensive. The drug also had other problems, mainly that it appeared to inhibit lung function. The lung problems were well known, and stalled Exubera's approval for years.
Despite its decision late last year to suspend marketing of Exubera, Pfizer had allowed it to remain on the market so current users had time to transition to traditional insulin. Meanwhile, Pfizer's partner, Nektar Therapeutics of San Carlos, Calif., was seeking a new marketing partner for Exubera. However, the announcement of a lung cancer - Exubera connection has prompted Nektar to stop that search. Pfizer is now ceasing all Exubera shipments and will no longer manufacture it.
According to The Wall Street Journal, about 1,200 Exubera patients were in the process of transitioning to traditional insulin and 2,800 remained in clinical trials. Pfizer said yesterday that in clinical trials of Exubera, there had been 6 newly diagnosed cases of primary lung malignancies among Exubera-treated patients, and only 1 newly diagnosed case among not treated with Exubera. The company said it had also received a report of a newly diagnosed lung cancer case after Exubera was brought to market.
Pfizer said on Wednesday it updated the Exubera label to include safety information about lung cancer cases found in patients who used Exubera. The warning states all patients who developed lung cancer had a history of cigarette smoking, and that too few cases existed to determine whether the development of lung cancer is related to Exubera use.
According to The Wall Street Journal, Pfizer knew about three of the lung cancer cases in the Exubera clinical trials when it petitioned the Food & Drug Administration (FDA) for approval in 2005, and that data was given to the agency. A spokesperson for the FDA told the Journal that the agency didn't note the cancer cases in the product label when it approved Exubera in early 2006, because they weren't statistically meaningful and reflected a common problem in smokers. The FDA recently requested that Pfizer update the product's label because the reports were increasing and crossed a "threshold," the spokesperson said.
There was once great hope that inhaled insulin products could spare diabetics from painful injections. Since Pfizer suspended marketing Exubera last year, Eli Lilly and Novo Nordisk also ended inhaled insulin development programs. Only one other company, MannKind Corp., has continued to develop an inhaled insulin. According to Reuters, that company has been steadfast in its commitment to its experimental inhaled insulin, Technosphere Insulin, saying it held advantages over the other products.