The FDA's Alzheimer's Mistake Is Already Worsening
The controversial approval of Biogen's Alzheimer's drug has Eli Lilly pushing forward with limited evidence.
The FDA lowered its standards on Alzheimer's drugs. Now Eli Lilly thinks it can clear the bar.
Photographer: Nomadsoul1/iStockphotoWhen the U.S. Food and Drug Administration approved Biogen Inc.'s controversial Alzheimer's drug Aduhelm earlier this month without firm evidence that the drug helps patients, it created concern that other unproven treatments might follow. That scenario is already here.
Eli Lilly & Co. announced Thursday that it plans to file for accelerated approval for its experimental Alzheimer's treatment donanemab this year based on its ability to clear amyloid brain plaques believed by some to cause the disease. That's the same unprecedented justification and pathway the FDA used for Aduhelm. Lilly is clearly reacting to the agency's shifted goalposts; in April, the company told investors it wouldn't seek a quick approval because the regulator said there wasn't enough data.