Kisunla for Alzheimer’s Expands to Japan

INDIANAPOLIS, Sept. 2024 /PRNewswire/ — The Ministry of Health, Labour and Welfare Japan has approved Kisunla™ (generic name: donanemab).

Japan is the second major market in which Kisunla has been approved for use.

How Big is This News for Kisunla?
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In Japan, by 2030, the number of patients with dementia is estimated to be more than 5 million¹, and Alzheimer’s disease (AD) is the most common cause of dementia, accounting for more than 67% of cases². The number of AD patients is expected to increase significantly compared with other dementias.³ 

“Lilly scientists have been dedicated to research in Alzheimer’s disease for more than 35 years, and this news is testament to their ingenuity, perseverance, and commitment to helping people with this disease,” said Ilya Yuffa, executive vice president and president of Lilly International, Eli Lilly and Company. “Kisunla demonstrated very meaningful results for people with early symptomatic Alzheimer’s disease by significantly slowing cognitive and functional decline in our TRAILBLAZER-ALZ 2 study, which included participants from Japan. People around the world want and deserve access to treatment options for this devastating disease. Today’s news is another critical step in ensuring patients with Alzheimer’s disease can receive treatment with these first class of amyloid therapies, which could give them more time to do what matters most to them.” 

What is Kisunla and Who Is It For?

• Kisunla, pronounced kih-SUHN-lah, is made by Eli Lilly and Company’s (NYSE: LLY).
• The name Kisunla is Ely Lilly’s brand name for the generic drug donanemab-azbt.
• Kisunla is not a pill. It is administered in doses of 350 mg/20 mL, every four weeks, by injection for IV infusion.
• Kisunla is approved as an 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.

How Does Kisunla Work?

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.^4,5 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.^4-7

“Alzheimer’s disease is a significant healthcare burden in Japan due to the rapidly aging population. We are excited to make Kisunla available in Japan as a new treatment option for early symptomatic Alzheimer’s disease,” said Yanping Wang, senior vice president of Drug Development and Medical Affairs at Eli Lilly Japan. “Patients treated with Kisunla may have the option to stop treatment once the amyloid plaques are removed, which could help reduce the infusion burden for eligible patients.”

How Do You Take 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.

Clinical Trial Results from Kisunla’s TRAILBLAZER-ALZ 2 Phase 3 Study

The application to the PMDA was based on the efficacy and safety data from TRAILBLAZER-ALZ 2 Phase 3 clinical study.

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.^8-10 Treatment with Kisunla significantly slowed clinical decline in both groups.⁸  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%.^8, 11 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.¹²   

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.^{8, 13} 

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. In the TRAILBLAZER-ALZ 2 study, 66% of patients achieved plaque clearance (based on above criteria) at one year.¹⁴

Side Effects of Kisunla Treatments

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.^8,15 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. 

Kisunla™ (donanemab) Summary

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.  

How Do I Get Kisunla?

For more information about Kisunla, call 1-800-LillyRx (1-800-545-5979) or go to kisunla.lilly.com.

This summary provides basic information about Kisunla. It does not include all information known about this medicine. Read the information below, as well as 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.

Facts 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 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.

OFFICIAL: U.S. INDICATION AND SAFETY SUMMARY WITH WARNINGS

Kisunla™ (donanemab-azbt), pronounced 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 headaches, 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 www.fda.gov/medwatch.

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.