Manufacturing Industry
LILLY (ELI) & COMPANY - Additional Clinical Trial Required for Ruboxistaurin.
PR Newswire UK Disclose, September, 2006
Lilly Announces FDA Requirement of Additional Clinical Trial Before
Ruboxistaurin Could Be Approved for Treatment of Diabetic Retinopathy
Additional Trial Would Take Up To Five Years to Complete; Lilly Currently
Evaluating Options
INDIANAPOLIS, Sept. 29 /PRNewswire-FirstCall/ -- Eli Lilly and Company today
announced that it is weighing options for the further development of
ruboxistaurin mesylate in light of a request by the Food and Drug
Administration (FDA) for an additional, three-year, Phase 3 clinical trial. The
FDA said it wants additional efficacy data before it will consider approving
the molecule for the treatment of moderate to severe nonproliferative diabetic
retinopathy. Lilly believes that such a trial would require up to five years to
complete....
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