Pfizer has pushed back its Exubera timetable again, saying that full roll-out of the inhalable insulin product will not come before early 2007.
“An expanded [launch] of Exubera to US primary-care physicians, previously targeted for November, will begin next January,” the company said in its third-quarter statement.
Exubera, approved in February for use in Type 1 and Type 2 diabetes, was set to reach pharmacy shelves by mid-July. Pfizer changed the date to early September and then November before announcing the new delivery time of January, which is nearly a year after US approval.
The company said it has encountered "issues" with Exubera's “innovative and complex manufacturing process” but has made "significant progress" in addressing them.
Exubera is sold in several European markets, and a comprehensive education and training program for US physicians and patients is under way, Pfizer said.
The FDA advisory committee that reviewed Exubera prior to approval had registered concerns about its potential adverse lung effects.
“[Exubera], which analysts had predicted would be a blockbuster, now appears to be running into widespread resistance from doctors concerned about its potential risks to the lungs,” The New York Times reported.