ArxxantTreatment for Diabetic Retinopathy
Eli Lilly and Company Announces Approvable Letter Issued by FDA for Arxxant
INDIANAPOLIS, August 18, 2006 -- Eli Lilly and Company announced today that it received an approvable letter from the U.S. Food and Drug Administration (FDA) for ruboxistaurin mesylate (proposed trade name Arxxant, pronounced, ark-ZONT), its investigational oral therapy being studied for treatment of diabetic retinopathy (DR), 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 (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, Vice President of Global Regulatory Affairs, Eli Lilly and Company.
Arxxant is an investigational therapy for the treatment of moderate to severe non-proliferative diabetic retinopathy. It 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.
Lilly submitted a new drug application (NDA) to seek approval from the U.S. Food and Drug Administration for ruboxistaurin for the treatment of moderate to severe non-proliferative diabetic retinopathy in February 2006.
About Diabetic Retinopathy
Diabetic retinopathy (DR) occurs when diabetes damages the small blood vessels in the retina, a part of the eye that is needed for vision. This damage can lead to vision loss and possible blindness. DR affects an estimated 4.1 million Americans age 40 and older with 899,000 having a vision- threatening form of the disease,1 and it is the leading cause of blindness among working-age adults.2
1. Kempen, et al.: The Prevalence of Diabetic Retinopathy Among Adults in the United States. Arch Ophthalmol, 122:552-563 (2004).
2. Fong, et al.: Retinopathy in Diabetes. Diabetes Care, 27:584-587 (2004)
Source: Eli Lilly and Company
- Lilly Will Submit Arxxant to FDA in 2005 August 2, 2005
Posted: August 2006
- Lilly Announces FDA Requirement of Additional Clinical Trial Before Ruboxistaurin Could Be Approved for Treatment of Diabetic Retinopathy - September 29, 2006
- Lilly Will Submit Arxxant to FDA in 2005 - August 2, 2005