FDA panel backs Exubera

FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 7-2 in favor of recommending approval for Exubera inhaled insulin powder from Pfizer (PFE) and sanofi-aventis (Euronext:SAN; SNY) to treat Type I and Type II diabetes. While both PFE and FDA focused their presentations on pulmonary safety data, members of the committee also were concerned about the real-world use of the device and called on the company to ensure that adequate training in its use be provided to both physicians and patients.

Discussion of pulmonary effects generated the most dissent. Although the committee unanimously agreed that it had seen sufficient data to assess pulmonary safety in patients without underlying lung disease, it voted 4-5 on whether there were enough data in patients with diseases such as chronic obstructive pulmonary disease (COPD) and asthma. One of the five members who voted no said that he would have voted yes had two ongoing studies in those patient populations already been completed. ...