FDA demands new trial for Lilly's Arxxant

The FDA is demanding that Eli Lilly undertake a new three-year, late-stage trial to demonstrate the efficacy of its diabetic eye disease therapy, dubbed Arxxant. Lilly had received an approvable letter in August and had hoped that the FDA's concerns could be satisfied from the existing data. Now the drug developer says they're going to continue ongoing studies while pondering the agency's demand for a new pivotal trial of ruboxistaurin, which Lilly says would actually take five years to complete.

- read the AFX report on Lilly's dilemma