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Eisai Aricept "not approvable" for VaD

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Eisai/Pfizer's Alzheimer's therapy Aricept (donepezil) is "not approvable" for vascular dementia claim, FDA says July 3. FDA found that the application contained insufficient information to support an approval at this time, the firm said. Eisai plans to have discussions with FDA as to the next regulatory step. FDA's Peripheral & Central Nervous System Drugs Advisory Committee was scheduled to review the sNDA May 16, but the meeting was cancelled. At a March 2001 meeting, the committee had debated whether VaD was a distinct clinical entity. Aricept is the first agent to be filed for VaD, but Janssen's Reminyl (galantamine) and Novartis' Exelon (rivastigmine) are both in Phase III for the condition (1Pharmaceutical Approvals Monthly Oct. 1, 2002, p. 23
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