2. INDIANAPOLIS, Aug. 18 /PRNewswire-FirstCall/ -- Eli Lilly and Company announced today that it received an approvable letter from the U.S. Food and Drug Administration (FDA) for ruboxistaurin mesylate (proposed trade name Arxxant(TM), pronounced, ark-ZONT), its investigational oral therapy being studied for treatment of diabetic retinopathy (DR), a diabetic eye disease. In its letter, the FDA has requested submission of additional data to support the clinical evidence presented by Lilly in its new drug application (NDA). Lilly plans to meet with the FDA to determine whether this request can be satisfied with data from an ongoing study or whether a new study is required. "We will be working closely with the FDA to address issues outlined in the approvable letter and to define the pathway forward," said Dr. Timothy R. Franson, Vice President of Global Regulatory Affairs, Eli Lilly and Company. About Arxxant Arxxant is an investigational therapy for the treatment of moderate to severe non-proliferative diabetic retinopathy. It works by limiting the overactivation of protein kinase C beta (PKC b), 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 non-proliferative diabetic retinopathy. Lilly submitted a new drug application (NDA) to seek approval from the U.S. Food and Drug Administration for ruboxistaurin for the treatment of moderate to severe non-proliferative diabetic retinopathy in February 2006.
3. Eli Lily to review Arxxant development after FDA request Saturday, September 30, 2006 8:17:20 AM ET newratings.com NEW YORK, September 30 (newratings.com) – Eli Lily & Co (LLY.NYS) Friday announced that the US Food and Drug Administration (FDA) had asked the company to submit additional effectiveness data on ruboxistaurin mesylate before considering approving the drug for the treatment of moderate to severe diabetic retinopathy. The FDA had granted an approvable letter for the drug, Arxxant, in August this year. Eli Lily said the additional data required by the FDA will be available only after the completion of a five-year clinical trial . The company added that it will have to review the feasibility of continuing the drug’s development. Arxxant would be the first oral drug to treat diabetic retinopathy, a major cause of blindness among working age adults.
4. NEW YORK, Nov 13 (Reuters) - Eli Lilly and Co. (LLY.N: Quote, Profile, Research) on Monday said its once-daily experimental pill Arxxant reduced vision loss by 40 percent , compared with placebo, in a 3-year late-stage trial of patients with moderate-to-severe diabetic retinopathy. Diabetic retinopathy, an eye-threatening condition in which diabetes damages small blood vessels in the retina, affects more than 4 million Americans age 40 and older. It is the leading cause of blindness among working-age adults. Indianapolis-based Lilly said vision loss -- defined as a three-line loss on a standard eye chart that continues for at least 6 months -- occurred in 5.5 percent of patients treated with Arxxant, the chemical name for which is ruboxistaurin. That compared with 9.1 percent of patients given placebos during the study. The 40 percent reduced risk for Arxxant in the 685-patient trial was statistically significant.
5. Revue de Presse Ruboxistaurine (RBX) 7 février 2006 JFGirmens
