Bad News on Cymbalta Becomes Official

We know things can get pretty hectic around the holidays, so perhaps we shouldn't be surprised that people didn't find time to read this piece published by "The Pink Sheet" DAILY on Dec. 11: Cymbalta's Chronic Pain Woes Continue As Advisory Committee Faces Cancellation.

When FDA made the official announcement nearly a month later, stating that it needed time "to review new information that is relevant to the benefit risk balance for the proposed new indication," we found it unremarkable, because, well, we had already remarked on it.

But Wall Street seemed a little surprised, sending Lilly's stock down almost two percent. Investor concern is legitimate; Cymbalta is among the last of Lilly's stalwarts headed for the patent cliff, but off it will go by 2014, so any delay in a label expansion will be acutely felt by the firm. Still, to us it feels like a reaction to old news.

Lilly, for its part, says it "has submitted one new efficacy/safety study with the routine 120-day safety update. This study, however, did not show any new safety signals. We also continue to respond to questions from FDA staffers as part of the normal sNDA review process."

Our best guess about what lead to the committee cancellation is still a safety issue: FDA may be mulling the risk management options for Cymbalta and whether it needs to run them by an advisory committee. In the new REMS era, applications that haven't included a proposal have often seen their reviews delayed. And even as FDA pledges to start meeting user fee deadlines again (did you miss that too?) those extra safety requirements may require developers and analysts to adjust their expectations.

The lesson for industry and investors alike: Know your Sheet. Er, read "The Pink Sheet" DAILY carefully.

image by flickrer Gullig used under a creative commons license