Lilly Gets Approvable Letter for Arxxant

Eli Lilly and Co. received an approvable letter from the FDA for ruboxistaurin mesylate (proposed trade name Arxxant), its investigational oral therapy for treatment of diabetic retinopathy (DR), a diabetic eye disease.

As part of the letter, the FDA has requested additional data to support the clinical evidence presented by the company in its NDA. Lilly 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,” said Dr. Timothy R. Franson, Lilly’s vice president of global regulatory affairs.

Arxxant works by limiting the overactivation of protein kinase C beta (PKC b), a naturally occurring enzyme that has been linked to the development of diabetic retinopathy. It is the first of a new class of compounds being investigated for the treatment of moderate to severe non-proliferative diabetic retinopathy.