Lilly Arxxant woes continue
Executive Summary
FDA rejects Eli Lilly's appeal of the agency's "approvable" decision on diabetic retinopathy treatment Arxxant (ruboxistaurin), the company announces March 12. Lilly says it will not continue to pursue the appeal and is considering options for Arxxant, including conducting additional trials previously requested by FDA, seeking a partner to further develop the drug or terminating the program. As part of its approvable decision, FDA asked for an additional three-year Phase III clinical trial. Lilly's initial submission included two three-year Phase III studies comparing ruboxistaurin to placebo (1"The Pink Sheet" Oct. 23, 2006, p. 10). Lilly also withdraws its marketing authorization application for Arxxant in the EU...