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 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 Franson, vice president of global regulatory affairs at Eli Lilly.
Arxxant is an investigational therapy for the treatment of moderate to severe non-proliferative diabetic retinopathy. It works by limiting the over activation 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.