Chronic pain claim remains elusive for Lilly's Cymbalta
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
The spring 2010 user fee goal date for Lilly's chronic pain sNDA for Cymbalta (duloxetine) "passed without action," Lilly acknowledged in its first quarter earnings release. The company expects, "based on recent discussions with FDA," that the agency will schedule an advisory committee review in the second half of 2010. The regulatory delay is hardly unprecedented for the chronic pain claim, which would be Cymbalta's fifth indication. A previous advisory committee review, scheduled for Jan. 28, 2010, was cancelled in December 2009; no clear reason was given, though the need to review a risk management plan was considered a likely culprit (1"The Pink Sheet" DAILY, Dec. 11, 2009). A prior chronic pain sNDA was submitted and withdrawn in 2008 after FDA raised concerns about the statistical treatment of patients who did not complete the protocol. Lilly announced the resubmission in June 2009 with a more recent trial using FDA's preferred statistical treatment of drop-outs