Eli Lilly and Company (NYSE:LLY)’s investigational oral therapy being studied for treatment of diabetic retinopathy (DR), ruboxistaurin mesylate (proposed trade name Arxxant™, pronounced, ark-ZONT), received an approvable letter from the USFDA.
The USFDA has requested submission of additional data to support the clinical evidence presented by Lilly in its new drug application (NDA) for Arxxant™.
Lilly is going to meet with the USFDA to determine whether this request can be satisfied with data from an ongoing study or whether a new study is required.
Lilly’s NDA for Arxxant™ (ruboxistaurin) for the treatment of moderate to severe non-proliferative diabetic retinopathy has been submitted to the USFDA in February 2006.
Arxxant™ works by limiting the overactivation of protein kinase C beta (PKC b). PKC b is a naturally occurring enzyme that has been linked to the development of diabetic retinopathy.
Arxxant™ is the first of a new class of compounds being investigated for the treatment of moderate to severe non-proliferative diabetic retinopathy.
Source: Eli Lilly and
[Photo Credit: NEEC]
.jpg)
Comment Preview