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Home » FDA ISSUES APPROVABLE LETTER FOR LILLY'S ARXXANT
FDA ISSUES APPROVABLE LETTER FOR LILLY'S ARXXANT
August 21, 2006
Eli Lilly received an approvable letter from the FDA for Arxxant (ruboxistaurin mesylate), its investigational oral therapy for treatment of diabetic retinopathy, an eye disease.
In its letter, the FDA requested submission of additional data to support the clinical evidence in the new drug application. The company plans to meet with the FDA to determine whether this request can be satisfied with data from an ongoing study or if a new study is required.
Arxxant works by limiting the overactivation of protein kinase C beta, 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 its new drug application in February.
KEYWORDS Drug Pipeline Alert
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