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news.Eli Lilly has withdrawn a marketing application for diabetic retinopathy drug Arxxant in the EU after the company was not able to respond to a request for additional information in time.
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The news follows an announcement from the FDA that it would still need an additional three-year study on the drug before approval in the US, rejecting an appeal from Lilly against the decision.
Arxxant was expected to be used for the treatment of moderate to severe non-proliferative diabetic retinopathy (damage to the blood vessels in the retina) in adult patients. Diabetic retinopathy is a complication of diabetes and can cause severe vision loss or even blindness.
At the time of the withdrawal, it was under review by the Agency’s Committee for Medicinal Products for Human Use (CHMP).