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...
You may also be interested in...
Rethinking Alzheimer's: Mapping Out an Approval Process
Drug companies involved in Alzheimer's disease research are a little fed up with FDA. Some, like Wyeth, believe the agency should put Alzheimer's research higher up on its priority list and allow the use of surrogate endpoints for clinical trials. But FDA says that no validated surrogate exists for Alzheimer's, and until it has hard data from products in development, it is loath to recommend one. A recent reorganization of the agency's neurology group may provide an opening to press home those arguments.
US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising
US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.