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Lilly Arxxant retinopathy NDA in 2005

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Lilly plans to submit an NDA "at the end of 2005" for use of ruboxistaurin (Arxxant) in diabetic retinopathy, the firm says Aug. 2. Lilly no longer plans to seek an indication for treatment of symptoms of diabetic peripheral neuropathy due to the protein kinase C-beta inhibitor's failure to meet its primary endpoint in two Phase III trials. An NDA had been planned for the second half of 2005 (1Pharmaceutical Approvals Monthly May 2005, In Brief). However, the company is continuing a Phase III trial looking at treatment of nerve dysfunction in DPN, slated to be complete in 2007. A study in diabetic macular edema is expected to complete in 2010...

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