An advisory committee to the Food and Drug Administration unanimously backed Eli Lilly’s Alzheimer’s drug donanemab for approval Monday evening.
In an 11-0 vote, the adcomm said donanemab is effective for treating Alzheimer’s and that its benefits outweighed the risks.
The advisory committee voted in favor of donanemab use across a broad spectrum of patients with Alzheimer’s disease due to issues with practicality and limited access to tau PET.
The group of external, independent experts also expressed comfort in extrapolating clinical data thanks to supporting biomarker evidence, even though patients with very low or no tau were excluded from the drug’s pivotal program.
This a major clinical development for Lilly after the FDA rejected its accelerated approval submission for donanemab in January 2023. At the time, the federal health agency requested additional data from the drugmaker.
In the intervening period, another Alzheimer’s treatment — Biogen and Eisai’s Leqembi — won FDA approval in a watershed moment for addressing the disease and its symptoms before making its debut on the commercial market.
According to Biogen’s latest earnings report released in late April, the drug achieved global in-marketing sales of $19 million in Q1 2024, well outpacing the $7 million of sales in Q4 2023.
Pamela Spicer, therapy area director at Citeline, wrote in commentary to MM+M that the adcomm’s recommendation for donanemab’s use across all tau subgroups will better position the drug to rival Leqembi and broaden neurologists’ armamentarium going forward.
She added that additional data will “likely need to be gleaned in a post-market setting on efficacy and safety” after treatment discontinuation as well as in underrepresented populations.
Spicer added that the Alzheimer’s care community would likely celebrate this adcomm vote while determining a potential safety trade off — particularly in the “higher-risk APOE4 homozygotes,” which might be offset by donanemab’s promise for limited duration.
She was correct in her prediction about the immediate reaction, with patient advocacy organizations issuing press releases welcoming the news Monday evening and Tuesday morning.
The Alzheimer’s Association said donanemab would be a powerful complement on the market to Leqembi.
“A future with more approved Alzheimer’s treatments is a tremendous advancement for people eligible for these drugs. Progress with treatment is happening,” Alzheimer’s Association CEO Joanne Pike, DrPH said in a statement.
Meanwhile, the Alzheimer’s Drug Discovery Foundation (ADDF) added that this is a major step towards potential FDA and enlarges the treatment landscape for the memory-robbing disease.
“It’s encouraging to see that some patients essentially enter remission, where they achieve full amyloid clearance with donanemab, with no resurgence in substantial plaque buildup for nearly four years,” ADDF chief science officer Dr. Howard Fillit said in a statement. “These findings are a direct result of biomarker tests that can detect, quantify, and monitor plaque buildup in the brain. Biomarkers will continue to revolutionize clinical trial design as we move towards developing drugs that target novel pathways guided by the biology of aging.”
