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ADA Meeting In Brief

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Pfizer/Sanofi-Aventis Exuberant over Phase III data: Pooled data from two Phase III studies involving 304 adults with type 2 diabetes showed that those taking Exubera inhaled insulin maintained glycemic control for two years and "experienced no clinically important effects on pulmonary function compared to patients treated with oral agents alone," Pfizer says. Data from a third study of 384 adults treated during a two-year open label extension further support the findings, the firm reports. Also presented at the American Diabetes Association meeting in San Diego June 10-14 was a fourth study with 226 patients showing that after three months, Exubera was "well tolerated and as effective as subcutaneous (injectable) short-acting insulin in achieving tight glycemic control in adults with type 1 diabetes." The most common adverse events were hypoglycemia and cough. Exubera has a Jan. 1, 2006 user fee date following a March NDA filing for type 1 and 2 diabetes; the filing was delayed by pulmonary safety concerns (1Pharmaceutical Approvals Monthly March 2005, p. 12)...
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