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Unresolved Review Issues: Clinical Trials Are Easier Fix Than Safety, Efficacy

Executive Summary

Problems with clinical trial design and/or execution identified pre-submission are the issues most likely to be resolved in advance of first FDA action, Booz Allen Hamilton's first-cycle review report finds

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Yentreve NDA withdrawal (correction)

Lilly maintains that a QT prolongation signal was not a factor in the firm's decision to withdraw its application for the stress urinary incontinence therapy Yentreve (duloxetine), as suggested in a 1story in the Feb. 27 issue of "The Pink Sheet" regarding Booz Allen's first-cycle review report. According to review documents for duloxetine in treatment of depression, approved under the trade name Cymbalta, FDA's Division of Reproductive & Urologic Drug Products was concerned that duloxetine may have the potential to prolong the QT interval in patients receiving CYP2D6 and CYP1A2 inhibitors. The division felt the issue needed to be addressed pre-approval due to the common use of CYP2D6 and CYP1A2 inhibitors in the SUI population. Lilly says the withdrawal was due to Yentreve's risk/benefit ratio...

Yentreve NDA withdrawal (correction)

Lilly maintains that a QT prolongation signal was not a factor in the firm's decision to withdraw its application for the stress urinary incontinence therapy Yentreve (duloxetine), as suggested in a 1story in the Feb. 27 issue of "The Pink Sheet" regarding Booz Allen's first-cycle review report. According to review documents for duloxetine in treatment of depression, approved under the trade name Cymbalta, FDA's Division of Reproductive & Urologic Drug Products was concerned that duloxetine may have the potential to prolong the QT interval in patients receiving CYP2D6 and CYP1A2 inhibitors. The division felt the issue needed to be addressed pre-approval due to the common use of CYP2D6 and CYP1A2 inhibitors in the SUI population. Lilly says the withdrawal was due to Yentreve's risk/benefit ratio...

Mid-Phase III Meetings Suggested As Way To Increase First-Cycle Approvals

FDA should consider conducting mid-Phase III meetings with drug sponsors as a way to improve the likelihood of approving an application during the first review cycle, a report by Booz Allen Hamilton recommends

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