The FDA has rejected an appeal from Eli Lilly to reverse a decision requiring the company to complete an extra three-year study on its diabetic eye disease drug Arxxant, according to a report.
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Reuters said that the US drug regulator stood by the approvable letter that it sent Eli Lilly last September, which informed the drugmaker that a further study would be needed before the treatment could be approved.
Lilly's executive vice president for science and technology Steven Paul said that although the company was disappointed by the ruling, it would not seek to appeal and was considering its options for the product.