ELI LILLY WITHDRAWS ARXXANT APPLICATION IN EUROPE

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The European Medicines Agency (EMEA) said that Eli Lilly has formally withdrawn the application for marketing authorization for Arxxant.

Eli Lilly had developed Arxxant (ruboxistaurin) for the treatment of moderate to severe nonproliferative diabetic retinopathy, a complication of diabetes that can cause severe vision loss or even blindness. The company had submitted the application in May 2006.

In its official letter to the EMEA, the company stated that the withdrawal of the application was due to the fact that it is not able to respond to the EMEA Committee for Medicinal Products for Human Use's request for additional information within the allowed timeframe.

Last week Eli Lilly announced that it had appealed the approvable letter the FDA issued in response to the company's new drug application for Arxxant, but that the FDA rejected the appeal, reiterating its request for a second three-year Phase III trial.

The company said it would not pursue the appeal any further, and that it was weighing the options for the further development of the drug.