Donanemab
Generic name: donanemab
Dosage form: Intravenous infusion
What is donanemab?
Donanemab is Lilly's new investigational medicine for Alzheimer’s disease . Donanemab is an immunotherapy drug that slows down the rate at which memory and thinking skills decline; this means that Alzheimer’s disease does not progress as quickly compared to patients who do not take Donanemab. When Alzheimer’s patients have been taking this medicine, they are able to continue daily activities and hobbies for a longer time as the rate of decline in their memory and thinking skills is slowed.
Is donanemab available yet?
Donanemab is not available yet, as FDA approval has not yet been applied for. It is still an investigational medicine that has undergone clinical trials, and Lilly is thought to be planning to file for FDA approval sometime in 2024.
Filing for FDA approval is dependent upon discussions with the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) about the Phase 3 TRAILBLAZER-ALZ 2 trial, which evaluated the efficacy and safety of donanemab in early symptomatic Alzheimer's disease.
How does donanemab work?
Donanemab works by targeting amyloid plaques in the brain that are thought to cause the symptoms of Alzheimer's disease, this helps slow the progression of Alzheimer’s symptoms. Donanemab is an immunotherapy drug that teaches the immune system to recognize and remove the amyloid plaques that build up in the brain.
How effective is donanemab?
Donanemab significantly slowed Alzheimer's disease progression in the TRAILBLAZER-ALZ 2 by more than 20% using the Integrated Alzheimer’s Disease Rating Scale (iADRS) and Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score at 76 weeks for those with low/medium tau and in the combined low/medium and high tau populations.
Treatment with donanemab benefited all groups of trial participants, regardless of tau level. Patients in earlier stages of the disease showed the most significant improvements.
How should I receive this medicine?
Donanemab is given as an infusion into your vein (IV infusion) every 4 weeks.
What is the brand name of donanemab?
As donanemab is not an approved medicine yet we do not know the brand name. We do know that when it was first being investigated in clinical trials it was given the development code name LY3002813.
Who will be able to use this medicine?
The studies for donanemab have been done on patients with early-stage Alzheimer’s disease. It is thought that it may not be effective for people who already have moderate to severe Alzheimer’s disease. When this medicine becomes approved by the FDA we will know which Alzheimer’s patients will be able to be prescribed it.
What are the side effects of donanemab?
In clinical trials side effects of this medicine included nausea, urinary tract infection, diarrhea, cerebral microhemorrhage, infusion-related reaction, vomiting, and anxiety.
This medicine can cause changes in the brain called amyloid-related imaging abnormalities (ARIA) which can be seen by MRI. In the TRAILBLAZER-ALZ clinical trial, the total number of donanemab patients who had amyloid-related imaging abnormalities was 38.9% compared to the placebo group, which had 8%.
There are two types of ARIA.
ARIA-E is when an MRI shows fluid accumulating in the brain (cerebral edema). Symptoms may include headaches, confusion, changes in mental state, vomiting, nausea, tremors, and gait disturbances. In the TRAILBLAZER-ALZ clinical trial, 27.5 % of donanemab patients experienced this side effect, and 0.8% in the placebo group.
ARIA-H is when an MRI detects small hemorrhages on the brain, these are sometimes called microhemorrhages. In the TRAILBLAZER-ALZ clinical trial, 30.5% of donanemab patients had ARIA-H compared to 7.2% of the placebo group.
How is donanemab different from Leqembi?
Donanemab and Leqembi (lecanemab) are both used for Alzheimer’s disease and both are directed against the amyloid plaques in the brain. Leqembi targets aggregated soluble and insoluble forms of amyloid beta, and donanemab targets amyloid plaques once they have been established.
Manufacturer
Eli Lilly and Company.
References
- Sims JR, Zimmer JA, Evans CD, et al. Donanemab in Early Symptomatic Alzheimer Disease: The TRAILBLAZER-ALZ 2 Randomized Clinical Trial. JAMA. 2023;330(6):512–527. doi:10.1001/jama.2023.13239
- Food and Drug Administration (FDA) Leqembi Product Label
- Mintun M, Lo A, Evans C, et al. Donanemab in Early Alzheimer's Disease. N Engl J Med. 2021. 384:1691-1704. doi: 10.1056/NEJMoa2100708.
- Amyloid structure linked to different types of Alzheimer’s disease
Further information
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