Another experimental Alzheimer’s drug can modestly slow patients’ inevitable worsening — by about four to seven months, researchers reported Monday.
Eli Lilly and Co. is seeking Food and Drug Administration approval of donanemab. If cleared, it would be only the second Alzheimer’s treatment convincingly shown to delay the mind-robbing disease — after the recently approved Leqembi from Japanese drugmaker Eisai.
Lilly announced in May that donanemab appeared to work, but on Monday the full results of a study of 1,700 patients was published by the Journal of the American Medical Association and presented at the Alzheimer's conference. “The modest benefits would likely not be questioned by patients, clinicians or payers if amyloid antibodies were low risk, inexpensive and simple to administer. However, they are none of these,” Dr. Eric Widera of the University of California, San Francisco, wrote in a JAMA editorial accompanying Lilly’s new data.
The results: Both groups declined during the 18-month study but overall those given donanemab worsened about 22% more slowly. Some patients fared better — those with low to medium tau levels saw a 35% slower decline, reflecting that the drug appears to work better in earlier stages of the disease. The main safety concern is brain swelling or bleeding, which often causes no symptoms but sometimes can be serious, even fatal. About a quarter of donanemab recipients showed evidence of that swelling, and about 20% had microbleeds.
It's too soon to know if some patients might need to resume donanemab, said Lilly's Dr. Mark Mintun. But the amyloid “doesn't come back with any sort of vengeance,” he said, speculating that might take several years.
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