Eli Lilly receives FDA approval letter for ruboxistaurin mesylate

The FDA sent an approval letter to Eli Lilly and Co. for ruboxistaurin mesylate (Arxxant), an investigational oral therapy for the treatment of diabetic retinopathy.

In the letter, the FDA requested additional data to support the clinical evidence presented by Lilly in its new drug application. Eli Lilly will meet with the FDA to determine if this request can be fulfilled with data from ongoing research or if a new study needs to be established.

“We will be working closely with the FDA to address issues outlined in the approval letter and to define the pathway forward,” said Timothy R. Franson, MD, vice president of global regulatory affairs, Eli Lilly and Co.