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Donanemab approved by the FDA for the Treatment of Early Symptomatic Alzheimer’s

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Donanemab approved by the FDA for the Treatment of Early Symptomatic Alzheimer’s

With FDA Approval for Donanemab confirmed, it now has a new name…. welcome to Kisunla™ for the Treatment of Early Symptomatic Alzheimer’s Disease.

INDIANAPOLISJuly 2, 2024 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) approved Kisunla™ (donanemab-azbt, 350 mg/20 mL once-monthly injection for IV infusion), Eli Lilly and Company’s (NYSE: LLY) Alzheimer’s treatment for adults with early symptomatic Alzheimer’s disease (AD), which includes people with mild cognitive impairment (MCI) as well as people with the mild dementia stage of AD, with confirmed amyloid pathology.1, 2 Once-monthly Kisunla is the first and only amyloid plaque-targeting therapy with evidence to support stopping therapy when amyloid plaques are removed, which can result in lower treatment costs and fewer infusions.3-6 

“Kisunla demonstrated very meaningful results for people with early symptomatic Alzheimer’s disease, who urgently need effective treatment options. We know these medicines have the greatest potential benefit when people are treated earlier in their disease, and we are working hard in partnership with others to improve detection and diagnosis,” said Anne White, executive vice president and president of Lilly Neuroscience, Eli Lilly and Company.

“Our deepest thanks to the patients and their loved ones for participating in our clinical programs and to Lilly scientists and collaborators persevering over decades of research. Each year, more and more people are at risk for this disease, and we are determined to make life better for them.”

Amyloid is a protein produced naturally in the body that can clump together to create amyloid plaques. The excessive buildup of amyloid plaques in the brain may lead to memory and thinking issues associated with Alzheimer’s disease.7, 8 Kisunla can help the body remove the excessive buildup of amyloid plaques and slow the decline that may diminish people’s ability to remember new information, important dates, and appointments; plan and organize; make meals; use household appliances; manage finances; and be left alone.1, 7-9

In the TRAILBLAZER-ALZ 2 Phase 3 study, people who were the least advanced in the disease experienced the strongest results with Kisunla. Trial participants were analyzed over 18 months in two groupings: one group who was less advanced in their disease (those with low to medium levels of tau protein) and the overall population, which also included participants with high tau levels.1, 10, 11 Treatment with Kisunla significantly slowed clinical decline in both groups.

Those individuals treated with Kisunla who were less advanced in their disease showed a significant slowing of decline of 35% compared with placebo on the integrated Alzheimer’s Disease Rating Scale (iADRS), which measures memory, thinking, and daily functioning. In the overall population, the response to treatment was also statistically significant using the iADRS at 22%.1, 12 Among the two groups analyzed, participants treated with Kisunla had up to a 39% lower risk of progressing to the next clinical stage of disease than those taking placebo.13

Among the overall population of participants, Kisunla reduced amyloid plaques on average by 61% at 6 months, 80% at 12 months, and 84% at 18 months compared to the start of the study.1, 14 One of the treatment goals of the study was to remove amyloid plaques to minimal levels consistent with a visually negative scan using amyloid positron emission tomography (PET). If participants were confirmed to have reached these levels, they were able to complete treatment with Kisunla and switch to placebo for the remainder of the study.

Kisunla can cause amyloid-related imaging abnormalities (ARIA), which is a potential side effect with amyloid plaque-targeting therapies that does not usually cause symptoms. It can be detected via magnetic resonance imaging (MRI) scans and, when it does occur, may present as temporary swelling in an area or areas of the brain, which usually resolves over time, or as small spots of bleeding in or on the surface of the brain. Infrequently, larger areas of bleeding in the brain can occur.1, 2 ARIA can be serious, and life-threatening events can occur.

Kisunla can also cause certain types of allergic reactions, some of which may be serious and life-threatening, that typically occur during infusion or within 30 minutes post-infusion. Headache is another commonly reported side effect. See the Indication and Safety Summary with Warnings below for additional information.

“This approval marks another step forward in evolving the standard of care for people living with Alzheimer’s disease that will ultimately include an arsenal of novel treatments, providing much needed hope to the Alzheimer’s community. As a physician, I am encouraged by the potential to stop treatment, which could reduce out-of-pocket costs and infusion burden for eligible patients,” said Howard Fillit, M.D., Co-Founder and Chief Science Officer at the Alzheimer’s Drug Discovery Foundation (ADDF). “Diagnosing and treating Alzheimer’s sooner than we do today has the potential to meaningfully slow disease progression, giving patients invaluable time to maintain their independence for longer.”

Cost and Coverage
In the TRAILBLAZER-ALZ 2 trial, people were able to complete treatment and switch to placebo at 6, 12, or 18 months after they achieved one of the study’s treatment goals, minimal levels of amyloid plaque consistent with a visually negative amyloid PET scan. In the overall population of people receiving Kisunla, 17% completed treatment at 6 months, 47% at 12 months, and 69% at 18 months based on an assessment of amyloid levels via an amyloid PET scan.1

                                             Kisunla Limited-Duration Treatment Examples                                              
Length of Treatment 6 months 12 months 18 months
30-Minute Infusions 6 13 19
Course of Therapy Cost $12,522 $32,000 $48,696
Note: The price of each vial of Kisunla is $695.65.

The total cost of Kisunla will vary by patient based on when they complete treatment. The FDA’s dosing instructions state that prescribers can consider stopping the dosing of Kisunla based on removal of amyloid plaques to minimal levels as observed on amyloid PET imaging. The potential to complete treatment after a limited-duration course of therapy, along with 30-minute infusions once per month, could result in lower patient out-of-pocket treatment costs and fewer infusions compared to other amyloid-targeting therapies.6

Patients’ out-of-pocket cost for treatment with Kisunla will depend on their length of treatment and their insurance. Coverage and reimbursement for Kisunla are now available for eligible patients on Medicare under a National Coverage Determination with Coverage with Evidence Development. Also, as of October 2023, broad coverage and reimbursement for amyloid PET scans are available for eligible patients on Medicare. More than 98% of eligible Medicare patients have coverage that eliminates, limits, or caps their annual out-of-pocket exposure.15

Lilly Support Services for Kisunla is a free support program committed to helping patients navigate treatment with Kisunla. The program includes offerings such as coverage determination assistance, care coordination, nurse navigator support, and customized support and resources. For more information about Lilly Support Services and Kisunla, visit or call 1-800-LillyRx (1-800-545-5979).

Lilly Donating to Lilly Cares Foundation

Lilly intends to donate Kisunla to the Lilly Cares Foundation, a separate nonprofit organization that makes medicines available at no cost to qualified Americans, including some Medicare beneficiaries, who meet financial eligibility and other criteria. This is consistent with Lilly’s long history of supporting access to our products to patients with financial need through medication donations to charitable organizations. Learn more about the Lilly Cares Foundation, including eligibility criteria, at

A media kit is available on with additional resources.

About Kisunla™ (donanemab-azbt)

Kisunla™ (donanemab-azbt) (pronounced kih-SUHN-lah) is an amyloid-targeting treatment for people with mild cognitive impairment (MCI) as well as people with mild dementia stage of early symptomatic Alzheimer’s disease, with confirmed amyloid pathology. Kisunla can cause serious side effects, including amyloid-related imaging abnormalities, or ARIA, and infusion-related reactions. Kisunla is a prescription medicine administered intravenously every four weeks, 700 mg for the first three doses and 1400 mg thereafter.

About TRAILBLAZER-ALZ 2 Study and the TRAILBLAZER-ALZ program

TRAILBLAZER-ALZ 2 (NCT04437511) is a Phase 3, double-blind, placebo-controlled study to evaluate the safety and efficacy of donanemab in participants with early symptomatic Alzheimer’s disease (MCI or mild dementia due to Alzheimer’s disease) with the presence of confirmed Alzheimer’s disease neuropathology. The trial enrolled 1,736 participants, across 8 countries, selected based on cognitive assessments in conjunction with evidence of Alzheimer’s disease pathology. The Phase 3 TRAILBLAZER-ALZ 2 study results were published in the Journal of the American Medical Association (JAMA).

Lilly continues to study donanemab in multiple clinical trials, including TRAILBLAZER-ALZ 3, which is focused on preventing symptomatic Alzheimer’s disease in participants with preclinical AD; TRAILBLAZER-ALZ 5, a registration trial for early symptomatic AD currently enrolling in China and Korea; and TRAILBLAZER-ALZ 6, which is focused on expanding our understanding of ARIA through novel MRI sequences, blood-based biomarkers, and different dosing regimens of donanemab.


Kisunla™ (kih-SUHN-lah) is used to treat adults with early symptomatic Alzheimer’s disease (AD), which includes mild cognitive impairment (MCI) or mild dementia stage of disease.

Warnings – Kisunla can cause Amyloid-Related Imaging Abnormalities or “ARIA.” This is a common side effect that does not usually cause any symptoms, but serious symptoms can occur. ARIA can be fatal. ARIA is most commonly seen as temporary swelling in an area or areas of the brain that usually goes away over time. Some people may also have spots of bleeding on the surface of or in the brain and infrequently, larger areas of bleeding in the brain can occur. Although most people do not have symptoms, some people have headache, dizziness, nausea, difficulty walking, confusion, vision changes, and seizures.

Some people have a genetic risk factor (homozygous apolipoprotein E ε4 gene carriers) that may cause an increased risk for ARIA. Talk to your healthcare provider about testing to see if you have this risk factor.

You may be at higher risk of developing bleeding in the brain if you take medicines to reduce blood clots from forming (antithrombotic medicines) while receiving Kisunla. Talk to your healthcare provider to see if you are on any medicines that increase this risk.

Your healthcare provider will do magnetic resonance imaging (MRI) brain scans before and during your treatment with Kisunla to check you for ARIA. You should carry information that you are receiving Kisunla, which can cause ARIA, and that ARIA symptoms can look like stroke symptoms. Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the symptoms listed above.

There are registries that collect information on treatments for Alzheimer’s disease. Your healthcare provider can help you become enrolled in these registries.

Warnings – Kisunla can cause serious allergic and infusion-related reactions. Do not receive Kisunla if you have serious allergic reactions to donanemab-azbt or any of the ingredients in Kisunla. Symptoms may include swelling of the face, lips, mouth, or eyelids, problems breathing, hives, chills, irritation of skin, nausea, vomiting, sweating, headache, or chest pain. You will be monitored for at least 30 minutes after you receive Kisunla for any reaction. Tell your healthcare provider right away if you have these symptoms or any reaction during or after a Kisunla infusion.

Other common side effects

  • Headache

Tell your healthcare provider right away if you have any side effects. These are not all of the possible side effects of Kisunla. You can report side effects at 1-800-FDA-1088 or

Before you receive Kisunla, tell your healthcare provider:

  • About all medicines you take, including prescription and over-the-counter medicines, as well as vitamins and herbal supplements. Especially tell your healthcare provider if you have medicines to reduce blood clots from forming (antithrombotic medicines, including aspirin).
  • About all of your medical conditions including if you are pregnant, breastfeeding, or plan to become pregnant or breastfeed. Kisunla has not been studied in people who were pregnant or breastfeeding. It is not known if Kisunla could harm your unborn or breastfeeding baby.

How to receive Kisunla
Kisunla is a prescription medicine given through an intravenous (IV) infusion using a needle inserted into a vein in your arm. Kisunla is given once every 4 weeks. Each infusion will last about 30 minutes.

Learn more
For more information about Kisunla, call 1-800-LillyRx (1-800-545-5979) or go to

This summary provides basic information about Kisunla. It does not include all information known about this medicine. Read the information given to you about Kisunla. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about Kisunla. Your healthcare provider is the best person to help you decide if Kisunla is right for you.

Please see full Prescribing Information including boxed warning for ARIA and Medication Guide for Kisunla.


Kisunla™ and Lilly Support Services™ are  trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

Alzheimer's Society LogoWhat did the Alzheimer’s Society have to say about the news?

Our Director of Research responds to news that the FDA has approved new Alzheimer’s disease drug donanemab in the US.

The Food and Drug Administration (FDA) has announced its approval in the US of the drug donanemab, a ground-breaking new treatment for early Alzheimer’s disease.

Fiona Carragher, Director of Research and Influencing at Alzheimer’s Society, said: “Donanemab is now the third drug aiming to slow down Alzheimer’s disease to be approved in the US, marking another step forward in the fight against dementia, the biggest health and social care challenge of our time.

We’re proud that Alzheimer’s Society funded research over thirty years ago which identified amyloid as important in the development of Alzheimer’s disease and has led to this moment today.

What does this mean for people in the UK?

“People affected by Alzheimer’s disease in the UK will wonder what this means for them – particularly as regulators did not approve aducanumab, which was also approved in the US a few years ago.

There are still many hurdles before donanemab could be available on the NHS.

“We now need to wait for the UK regulatory authority, the Medicines and Healthcare products Regulatory Agency (MHRA), to conduct its review of the donanemab data, and for The National Institute for Health and Care Excellenc (NICE )to evaluate its cost-effectiveness.

“This drug is only suitable for people in the early stages of Alzheimer’s disease, and until we fix dementia diagnosis in the UK, only small numbers of people will get the early, accurate diagnosis needed to access the treatment if it’s approved here.

“Right now, a third of people with dementia in the UK do not receive a diagnosis at all, so we need to see urgent investment into the specialist workforce and equipment needed to diagnose as many people as possible.”

A call to the NHS

“Donanemab is just one of nearly 130 potential treatments for Alzheimer’s disease being tested in trials, so it’s paramount we ramp up preparation for their arrival and roll-out.

“Alzheimer’s Society is urgently calling on the NHS to publish plans for how they intend to improve early diagnosis and deliver new treatments to the people who desperately need them.”

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