The company announced the findings from its phase 3 clinical trial in apress releaseWednesday.
In people with early symptomatic Alzheimers disease, the monthly antibody infusion slowed their loss of cognition.
Its not a cure.
Lara Antal / Verywell
These three drugs work by removing beta amyloid plaques from the brain.
BothAduhelmandLeqembiare already conditionally approved for use.
But as with its predecessors, Lillys monthly antibody infusion comes with significant safety risks.
Donanemab can cause brain swelling and bleeding that can, in rare cases, be severe or even fatal.
Lilly plans to file for FDA approval as soon as June.
This includes people with mild cognitive impairment and those in the mild dementia stage of the disease.
One of the primary goals of the study was to keep patients at their current cognitive state without progressing.
Patients undergoing treatment declined 40% less when it came to performing these daily activities.
There arent any studies directly comparing the anti-amyloid drugs, but donanemab and Leqembi appear work about as well.
Musiek said its reassuring that multiple different drugs that target amyloid have shown to be beneficial to cognition.
However, scientists disagree over amyloid plaques are the central driver of Alzheimers.
Were still talking about something thats a very modest clinical benefit, he said.
These include brain swelling and bleeding, including microhemorrhages.
Most of these cases were mild or moderate and were resolved, Lilly said.
ARIA was severe in 1.6% of participants.
Still, a clinical setting probably represents the best-case scenario for safety, Schrag said.
These kinds of numbers definitely get my attention.
That fear is a very nontrivial risk, Schrag said.
Musiek compared donanemab to chemotherapy.
Its a difficult drug.
All these drugs are all difficult, Musiek said.
Its a serious treatment for a serious disease.
About half the patients were able to stop the treatment within a year.
Another 20% completed it within 18 months.
Leqembi requires patients to get infusions twice a month, likely for the rest of their lives.
Donanemab, on the other hand, only requires infusion once a month.
Most patients may be able to stop the treatment after 12 to 18 months.
That means that patients arent necessarily committed to taking the drug long term, Schrag said.
However, the study only followed patients for 18 months.
Its important to remember, Schrag said, that this treatment isnt a cure.
It doesnt help patients to regain lost memory, but rather slows how quickly they lose it.
Leqembi costs $26,500 per year and Aduhelm costs $28,200 annually.
That means that insurers wont cover the hefty price tag for Leqembi and Aduhelm.
What This Means For You
Donanemab is not a cure for Alzheimers.
Brent RJ.Behavioral versus biological definitions of dementia symptoms: recognizing that worthwhile interventions already exist.OBM Geriat.
2019;3(4):1904079. doi:10.21926/obm.geriatr.1904079
