Novartis COX-2 setback
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Approval of Novartis' COX-2 inhibitor Prexige (lumiracoxib) could be delayed until 2005-2006 with the receipt of a Sept. 22 "not approvable" letter. FDA is requesting final data from the long-term TARGET study, additional data on the dose and dose interval in acute pain models, and an additional hip osteoarthritis study. TARGET results could be submitted third quarter 2004; an additional hip OA study would not be ready until the second half of 2005. The timeline could be accelerated if FDA accepts data from ongoing studies. Novartis will discuss requirements for individual trials with FDA "in the next two to four weeks." Global Pharma Development Head Joerg Reinhardt, PhD, assured investors Sept. 24 that FDA is "not addressing a specific liver enzyme elevation problem, it's an overall risk-benefit efficacy/safety assessment"...