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FDA review of Alzheimer’s drugs

Executive Summary

Approximately 60 percent of new drug applications for Alzheimer's therapies are approved by FDA in the first cycle, compared to 96 percent for HIV/AIDS drugs and 94 percent for selected cancer therapies, according to a report by Avalere Health. The consulting firm evaluated review times for five Alzheimer's therapies, 26 HIV/AIDS drugs, and 18 cancer treatments. "We found that the FDA met PDUFA review timelines for all drug categories; there was no evidence of a slower or delayed FDA review time for Alzheimer's," Avalere reports. However, HIV/AIDS and cancer drugs were more successful than Alzheimer's drugs at obtaining priority review and approval in the first cycle. The study was sponsored by Wyeth, which has 11 candidates under development to treat Alzheimer's disease, including bapinezumab, slated to enter Phase III in the second half of the year. Bapinezumab, codeveloped by Elan, has been granted fast track designation by FDA...

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