Indications -- diabetes Message Board

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Biotech / Medical : Indications -- diabetes

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From: scaram(o)uche	3/17/2007 12:32:52 AM
	of 278

[diabetic retinopathy/Lilly] Lilly dinged by FDA re. ruboxistaurin mesylate, an inhibitor of PKCbeta for diabetic retinopathy. Lilly was trying for approval with one pivotal study..... FDA rejects Lilly appeal of decision on Arxxant Tue Mar 13, 2007 3:19pm ET NEW YORK, March 13 (Reuters) - Eli Lilly and Co. (LLY.N: Quote, Profile , Research) said on Tuesday U.S. regulators rejected its appeal of a ruling that set back Arxxant, its experimental drug for diabetic eye disease, and the agency repeated a request for more study of the drug. The Food and Drug Administration last September said it would require the drugmaker to conduct a new three-year study before the drug could win marketing clearance. Lilly appealed the "approvable" letter issued by the FDA, but the agency rejected that appeal and reiterated the need for the study, said Steven Paul, Lilly's executive vice president for science and technology said at the Cowen & Co. investor conference, which was available by webcast. He said the company was disappointed with the agency's decision but that it would not appeal the ruling further and was considering its options for the product. today.reuters.com

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