Pfizer to delay submission of inhaled insulin for diabetes

Pfizer has reported that it "now seems likely" it will have to delayfiling of its inhaled insulin product Exubera, developed in collaboration with Inhale Therapeutics and Aventis and considered one of the most promising new drugs in its pipeline, after discussions with the US Food and Drug Administration. Many analysts have tipped Exubera as a potential blockbuster, while recognizing the problems that may be encountered in bringing such a novel therapeutic to market.

In Pfizer's statement for its second-quarter results (see page 2), the company said that, along with Aventis, it had completed the Phase III program for Exubera and the drug was scheduled for submission in the USA and Europe later this year. Noting that Exubera is a "first-in-class product" in the management of diabetes with a "large, complex New Drug Application," Pfizer said it was in discussions with the FDA over the content and timing of the NDA, but additional clinical data are probably required, pushing back a likely submission date into 2002.

The company maintains that the need for more data stems from the novelty of Exubera, although questions about the drug's long-term effectiveness were raised last month, when new clinical data revealed that patients on Exubera were four times more likely to develop antibodies against their insulin than those taking injectable insulin (Marketletter July 2). This finding followed an earlier negative for the program when Aventis reported that one patient in a 1,000-patient Exubera study suffered from scarring of the lungs.