First-line or second-line? That, apparently, is the big question for tomorrow's FDA advisory panel meeting. The committee on psychiatric products will consider Eli Lilly's new injectable form of the blockbuster schizophrenia drug Zyprexa. Yesterday, agency staff posted internal-review documents showing that about 1 percent of patients using this long-lasting Zyprexa--administered once every two or four weeks--experienced "profound" sedation.
The questions posted along with that review hint at the advisory committee's task. The first asks about the public health consequences of the sedative side effect. The second: How would the product label deal with it? To wit: "Would the labeling changes include a second line status and a black box warning?"
Of course, second-line status would mean that this version of Zyprexa would only be used if other treatments didn't work, limiting its sales potential. And a black box warning is never a boost to the bottom line. In its briefing materials, Lilly says it believes the potential for sedation can be managed, and that the benefits of the drug outweigh this risk.
After analyzing Lilly's data on the drug, FDA staff concluded that the drug is effective at treating schizophrenia. Tomorrow, we'll see whether the advisory panel agrees--and how they handle the safety question.
- read the FDA's questions to its advisory panel (.pdf)
- check out Eli Lilly's briefing materials for the meeting (.pdf)
- see the article in the Wall Street Journal
- find this summary in the Indianapolis Star
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