The FDA’s independent advisory committee has unanimously endorsed Eli Lilly’s experimental Alzheimer’s drug, donanemab, recognizing in particular its potential to slow cognitive decline in early-stage patients. This decision could soon position donanemab as the second FDA-approved amyloid-targeting drug for Alzheimer’s, joining Leqembi.
Alzheimer’s, affecting over six million Americans, lacks curative treatments. Donanemab, designed to target specific portions of the brain, demonstrated a modest cognitive decline slowdown in clinical trials. Patients who received the drug experienced cognitive stability for 4½ to 7½ months longer than those on a placebo. Additionally, nearly half of donanemab recipients maintained their cognitive level after a year, compared to 29% on a placebo.
However, donanemab’s safety profile presents concerns. The drug’s use led to brain swelling and bleeding in some participants, with three deaths linked to these side effects. Despite these risks, the advisory committee deemed the potential benefits crucial, given the severe impact of Alzheimer’s.
While the FDA typically follows advisory panel recommendations, approval is not guaranteed. The need for more diverse clinical data was highlighted, as most trial participants were white. Nonetheless, the endorsement marks a significant step in addressing Alzheimer’s, offering hope for slowing its progression and improving patient quality of life.
