FDA REJECTS ELI LILLY'S APPROVABLE LETTER APPEAL

Eli Lilly announced at a recent presentation that it appealed the approvable letter the FDA issued in response to the company's new drug application (NDA) for Arxxant, but that the FDA rejected the appeal. Furthermore, the FDA reiterated its requirement that Eli Lilly conduct a second three-year Phase III trial of the drug.

The company said it would not pursue the appeal any further, and that it is weighing the options for the further development of Arxxant (ruboxistaurin mesylate). The drug is being developed to treat moderate to severe nonproliferative diabetic retinopathy, an eye disease.

After submitting the Arxxant NDA in February 2006 and receiving priority review, Eli Lilly received an approvable letter from the FDA in August. When the FDA asked for another Phase III trial, the company said it believed such a trial would take up to five years to fully complete.

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.