BioCentury
ARTICLE | Regulation

Lilly’s Alzheimer’s therapy likely to get similar label to others in amyloid class

Missing or weak data in subgroups should not interfere with approval of donanemab for all patients with early disease, FDA panel concludes

June 10, 2024 11:22 PM UTC

Approval of Eli Lilly’s anti-amyloid Alzheimer’s treatment was already a near certainty. Now, an FDA advisory committee has unanimously agreed that tau PET imaging should not be a requirement for use of the therapy and that data on a variety of subgroups — related or unrelated to tau — can be collected postmarket. 

The two voting questions in the June 10 meeting of the Peripheral and Central Nervous System Drugs Advisory Committee were simply about whether donanemab is effective and whether its risk-benefit profile is positive for patients with mild cognitive impairment or mild dementia. Not surprisingly, the panel voted 11-0 in favor of the drug in both cases. ...

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Eli Lilly and Co.

BCIQ Target Profiles

Beta amyloid