FDA REQUESTS ANOTHER TRIAL TO SUPPORT LILLY'S ARXXANT NDA

Eli Lilly announced it is weighing options for the further development of ruboxistaurin mesylate in light of a request by the FDA for an additional three-year, Phase III trial to support the company's new drug application (NDA). The FDA said it wants additional efficacy data before it will consider approving the molecule for the treatment of moderate to severe nonproliferative diabetic retinopathy. Lilly believes that such a trial would require up to five years to complete.

The company received an approvable letter from the FDA Aug. 18. An NDA for ruboxistaurin with the proposed brand name Arxxant was submitted to the FDA in February and was granted priority review. Lilly said it does not intend to withdraw the NDA at this time, because withdrawal would require restarting the review process should Lilly ultimately move forward with development of ruboxistaurin.

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 nonproliferative diabetic retinopathy.