Donanemab Approved for Treatment of Early Alzheimer's Disease

Donanemab (Kisunla™) is an anti-amyloid antibody intravenous (IV) infusion therapy that is delivered every four weeks. It has received traditional approval from the U.S. Food and Drug Administration (FDA) to treat early Alzheimer's disease, including people living with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease who have confirmation of elevated beta-amyloid in the brain.

By slowing progression of the disease when taken in the early stages of Alzheimer's, donanemab can allow people to have more time to participate in daily life and live independently. Individuals should talk with their health care provider to develop an Alzheimer's treatment plan that is right for them, including weighing the benefits and risks of all approved medications and therapies.

Fore more information about donanemab, see below. Contact the Alzheimer’s Association 24/7 Helpline at 800.272.3900 for support or with additional questions.

Donanemab FAQs

Is donanemab a cure for Alzheimer's and all other dementia?

No. Donanemab is not a cure, but it has been shown to slow disease progression in clinical trials.

We will continue our efforts to discover new targets and test new and more effective treatments for Alzheimer's and all other dementia.

The Alzheimer's Association remains committed to advancing all potential treatment avenues and exploring methods for combining diverse approaches into combination therapies.

Who should take this drug?

The FDA prescribing information specifies that donanemab is appropriate for people living with early symptomatic Alzheimer's disease, which includes mild cognitive impairment and the mild dementia stage of Alzheimer's disease, with confirmed amyloid plaques. The treatment was studied in people living with mild Alzheimer's dementia and MCI due to Alzheimer's who showed evidence of a buildup of beta-amyloid plaques in the brain. The therapy has not been tested on people with more advanced stages of Alzheimer's or those without clinical symptoms.

Will this drug restore memories or cognitive function that has been lost?

There is no evidence to date that this or any treatment can restore or reverse memory loss or cognitive function due to Alzheimer's disease.

In the study results, the treatment effect continued to increase relative to placebo over the course of the trial, with the largest differences versus placebo seen at 18 months.

What type of diagnostic test is the FDA requiring?

There is no single diagnostic test that can determine if a person is living with Alzheimer's. Physicians use a variety of approaches and tools to help make a diagnosis. To diagnose Alzheimer's, physicians may use medical history, mental status tests, physical and neurological exams, biofluid (CSF and blood) tests and brain imaging.

Before initiating this anti-amyloid treatment, the prescribing information requires that a physician confirms the presence of beta-amyloid plaques. The FDA does not specify a diagnostic tool to determine elevated beta-amyloid, but tools such as an amyloid PET scan or lumbar puncture (CSF tests) are examples.

Your health care provider will also do a magnetic resonance imaging (MRI) scan before starting treatment with donanemab. Some people have a genetic risk factor (ApoE ε4 gene carriers) that may cause an increased risk for the side effect of amyloid-related imaging abnormalities (ARIA). The FDA encourages that testing for ApoE ε4 status should be performed prior to initiation of treatment to inform the risk of developing ARIA. Prior to testing, doctors should discuss with patients the risk of ARIA and the implications of genetic testing results.

How do I receive this treatment?

If you or a loved one is experiencing memory changes, the Alzheimer's Association strongly encourages speaking with a health care provider for a thorough evaluation and diagnosis. Individuals should talk with their health care provider to develop a treatment plan that is right for them, including weighing the benefits and risks of all approved therapies.

How much will this drug cost?

In a news release, the manufacturers of donanemab announced they are setting the price of the drug at $32,000 a year. Different from the first two approved therapies in this class, this drug was tested so that treatment was stopped once plaques were cleared from the brain. The cost of the treatment will vary based on patient and length of treatment.

Call the donanemab Copay Assistance Program at 800.LillyRx (800.545.5979) for financial information and support.

Will Medicare cover donanemab?

Currently, the Centers for Medicare & Medicaid Services (CMS) will cover these treatments only if prescribing physicians participate in a registry.

Will Medicaid cover donanemab?

Those eligible for both Medicare and Medicaid — either as a Full Benefit Dual Eligible (eligible for full Medicaid benefits) or in a Medicare Savings Program (Medicaid helping to cover some of the beneficiary's Medicare costs) — can receive coverage, with Medicaid's role being to cover the individual's 20% coinsurance payment. There may be additional requirements at the state level for those eligible for Medicaid and Medicare.

Will my insurance cover donanemab?

Insurance coverage will depend on an individual's provider and plan.

How is this drug administered?
The treatment is administered every four weeks through an IV, lasting about 30 minutes for each infusion. Typically, infusions can be done at hospitals and infusion therapy centers.

When will it be available at my doctor's office?

Now that the drug is approved, ramping up manufacturing — and eventually nationwide distribution and implementation — will take some time. Ask your doctor about availability.

What are the side effects?

All drugs have side effects. As with other anti-amyloid treatments in this class of drugs, donanemab does have side effects. Donanemab can cause serious allergic reactions. The most common reported side effects were amyloid-related imaging abnormalities (ARIA) and headache. These are not all of the possible side effects of donanemab, and individuals should talk with their doctors to develop a treatment plan that is right for them, including weighing the benefits and risks of all approved therapies.

Can I take this drug with my other medications/supplements? 

When considering any treatment, it is important to have a conversation with your health care provider to ensure you are a candidate for the treatment. This includes taking into account other health conditions, medications or supplements.

Tell your health care provider about all of the medicines you take, including prescription and over-the-counter drugs, vitamins and herbal supplements. Also be sure to tell your health care provider if you take medicines to reduce blood clots from forming (antithrombotic medicines, including aspirin). Ask for a list of these medicines if you are not sure.

How does donanemab compare to other monoclonal antibodies?

While monoclonal antibodies like aducanumab, donanemab and lecanemab that target beta-amyloid in the brain belong to the same class of treatments, no treatments are the same. They work differently by targeting beta-amyloid at different stages of plaque formation, and ultimately these treatments lower beta-amyloid to slow progression of the disease and to reduce clinical decline.