Eli Lilly's Arxxant gets FDA approvable letter; more data sought

By Elaine Rigoli

Tampa, Fla., Aug. 18 - Eli Lilly and Co. received an approvable letter from the Food and Drug Administration for ruboxistaurin mesylate (proposed trade name Arxxant), its investigational oral therapy being studied for treatment of diabetic retinopathy, a diabetic eye disease.

In its letter, the FDA has requested submission of additional data to support the clinical evidence presented by Lilly in its New Drug Application.

Lilly said it plans to meet with the FDA to determine whether this request can be satisfied with data from an ongoing study or whether a new study is required.

"We will be working closely with the FDA to address issues outlined in the approvable letter and to define the pathway forward," vice president of global regulatory affairs Timothy R. Franson said in a news release.

Indianapolis-based Lilly is a global pharmaceutical company.

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