The Indianapolis-based drug maker said that it was “weighing options” relating to ruboxistaurin mesylate (proposed brand name Arxxant).
The FDA said it wants additional efficacy data before it will consider approving the molecule for the treatment of diabetic retinopathy. Lilly believes that such a trial would take up to five years to complete. This request comes after Lilly received an approval letter for ruboxistaurin in August 2006.
The August approvable letter from the FDA requested additional efficacy data to support the clinical evidence presented by Lilly in its new drug application. The FDA made this recent request after trying to determine whether the additional evidence would come from ongoing trials or if a new trial would be required.
“We are certainly disappointed with this communication from the FDA. Diabetic retinopathy is a significant unmet medical need to which we have devoted more than a decade of clinical research with no guarantee of approval,” said Dr John Lechleiter, president of Eli Lilly.
Ongoing clinical trials for ruboxistaurin will continue while Lilly evaluates its options for further development of the diabetic treatment. Ruboxistaurin proposed brand name is Arxxant.
At this time, Lilly does not intend to withdraw the new drug application, because withdrawal would require restarting the review process, should the company ultimately move forward with development of ruboxistaurin.