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As last week ended, Eli Lilly disclosed a setback — the US Food and Drug Administration declined to approve its new biologic treatment for rheumatoid arthritis. The news, which was released on a day when the stock market was closed, came as a surprise and sent Lilly shares down nearly 4 percent so far today. And shares in Incyte, which would collect royalties on any sales, are down 10 percent.

The reactions reflect not only disappointment but considerable uncertainty. The reason is the FDA wants more clinical data to determine appropriate dosing as well as to address unspecified safety concerns. Lilly says it “disagree[s] with the agency’s conclusions,” but must now run further studies, and the eventual timing of any regulatory approval is unclear, which, of course, gives competitors a nice edge.

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  • Ed, this drug is not the first drug marketed by Lilly for rheumatoid arthritis. The first drug was Oraflex (benoxaprofen). It came on the market in 1982 and lasted all of 10 weeks, then pulled from the market because of serious safety issues, including liver failure, kidney failure and 49 deaths in the US. The company and its VP and Chief Medical Officer, Dr. Ian Shedden were charged with 25 federal counts of failure to disclose these side effects and deaths. Although the company got off with a light fine ($25,000) their reputation was sullied for a long time.

    Given this sordid history and the long institutional memory at FDA, can you blame the agency. for being cautious about a Lilly drug for rheumatoid arthritis with serious safety concerns?

    The ugly history below.

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