FDA sticks with demand for new Arxxant trial

Eli Lilly says that the FDA has rejected an appeal of its demand for a new trial of Arxxant, its would-be blockbuster for treating eye disease in diabetic patients. Arxxant had been one of Lilly's brightest drug prospects until the agency issued its decision. The drug developer, looking at a three-year study and huge new expenses for re-testing the drug, had asked the FDA to reconsider. But Lilly confirmed yesterday that its appeal had been nixed and no further appeal would be pursued. Lilly also pulled an application for European approval of the therapy. Lilly has already spent 10 years testing Arxxant and says it will now decide whether to go ahead with a new study, look for a partner to shoulder part of the cost or simply shutter the entire program.

- read the report from the Indianapolis Star

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