Lilly weighing ruboxistaurin options as FDA requests new trial

INDIANAPOLIS — The Food and Drug Administration has requested that Eli Lilly and Co. complete an additional 3-year, phase 3 clinical trial of ruboxistaurin mesylate before it will approve it as a treatment for diabetic retinopathy, the company announced.

Lilly is "weighing options for further development" of the drug in light of the FDA's request, according to a press release from the company.

The FDA informed Lilly that it wants additional 3-year efficacy data regarding the use of ruboxistaurin (proposed trade name Arxxant) for treatment of moderate to severe nonproliferative diabetic retinopathy. Lilly believes it could take up to 5 years to complete such a trial, according to the release.

The request for additional data follows Lilly's announcement in August that it had received an "approvable" letter from the FDA. Due to the request for an additional trial, Lilly is now weighing its options for further drug development, the release said.

"We are certainly disappointed with this communication from the FDA," John Lechleiter, PhD, president and chief operating officer of Eli Lilly, said in the release. "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. We still believe that ruboxistaurin has potential as a treatment for diabetic eye disease and are exploring the feasibility of further development of this molecule."

The trial data on ruboxistaurin were submitted to the FDA in February 2006, and the drug subsequently received priority review. In August, the FDA issued an approvable letter that requested additional efficacy data to support the clinical evidence submitted in the new drug application. The request for an additional trial stems from ongoing communication between Lilly and the FDA regarding whether additional evidence could come from ongoing trials or a new trial would be needed, the release said.

The company will continue with current ongoing clinical trials of ruboxistaurin while it evaluates its options for further development and currently does not intend to withdraw the new drug application; withdrawal would require restarting the review process should Lilly ultimately move forward with development of ruboxistaurin, according to the release.

In July, Lilly and Alcon announced a long-term agreement to jointly market Arxxant. The agreement was subject to the drug's approval by the FDA, according to an announcement at that time.