Rimonabant Acomplia News - FDA Asks Eli Lilly To Provide Addl. Data For Arxxant Dru

FDA Asks Eli Lilly To Provide Addl. Data For Arxxant Drug

18 Aug 2006

Drug manufacturer, Eli Lilly and Co. , revealed on Friday morning that it received an approvable letter from the U.S. Food and Drug Administration for ruboxistaurin mesylate or Arxxant, its investigational oral therapy for the treatment of moderate to severe non-proliferative diabetic retinopathy, a diabetic eye disease. The company also disclosed that the FDA sought additional data to supplement the clinical evidence presented by the company in its new drug application.

The Indianapolis, Indiana-based company said that Arxxant is the proposed trade name for the drug and added that the drug works by limiting the overactivation of a naturally occurring enzyme linked to the development of diabetic retinopathy, known as protein kinase C beta. Eli Lilly added that it intended to meet the FDA to determine whether the additional data from an ongoing study would be sufficient or another new study was required.

Timothy Franson, Vice President of Global Regulatory Affairs, Eli Lilly and Co., said that the company would work closely with the FDA to address issues mentioned in the approvable letter. The company had submitted a new drug application to FDA for Arxxant in February 2006.

An approvable letter is a notification that requires certain conditions to be satisfied before a drug obtains final marketing approval in the U.S. The company would now have to furnish additional data in order for the drug to be certified as marketable in the U.S.

Diabetic retinopathy is a condition that occurs when diabetes damages the small blood vessels in the retina, a part of the eye that is needed for vision. The damage to the retina could lead to vision loss and possible blindness, and is estimated to affect an estimated 4.1 million Americans. At present, some cases of diabetic retinopathy can be treated with laser surgery, while in advanced stages of proliferative diabetic retinopathy, the vitreous portion of the eye is removed by surgery and replaced with a clear solution.

Source:http://www.tradingmarkets.com

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