Savella: Do you recall FRX’s boast that they were going to out-detail LLY and PFE because FRX is purportedly more “focused” on fibromyalgia than those much larger companies? Based on the sales numbers, it doesn’t look like they’re succeeding.
The panel voted 8-5 in favor on approval for back pain but 9-4 against approval for osteoarthritis.
FDA label expansion for Cymbalta won’t help LLY much because the drug goes off-patent in the US in 2013. Moreover, the 3-year Hatch-Waxman marketing exclusivity for a new indication won’t matter in this case.