FDA wants more Pulminiq data

Chiron (CHIR) received an approvable letter from FDA for Pulminiq inhaled cyclosporine to prevent chronic lung transplant rejection. In the letter, the agency said another trial would be required for approval. The NDA was supported by a single double-blind, placebo-controlled Phase II trial in 58 patients that missed its primary endpoint of acute rejection but demonstrated a significant survival advantage. In June, an FDA advisory committee rendered a split decision on whether to recommend approval. CHIR said it is evaluating possible next steps; but in June, CMO Stephen Dilly told the committee that the company would not sponsor a new trial of Pulminiq without approval (see BioCentury, June 13, 2005). CHIR has exclusive worldwide rights to Pulminiq from Novartis (NVS; SWX:NOVN). The compound has Orphan Drug designation. ...