Lilly's Kisunla™ (Donanemab) Receives Approvals in Five Countries as First and Only Time-Limited Amyloid-Targeting Therapy for Early Alzheimer’s Disease
Eli Lilly
Global Pharmaceutical R&D and Production Company
· Kisunla is the first and only therapy to target and clear amyloid plaques through a limited dosing regimen.
· Kisunla was first approved in the United States in July 2024.
Statement:
1. The relevant indications for the drugs described in this article have not been approved in mainland China.
2. Eli Lilly does not recommend the use of any approved and/or unapproved drugs/indications.
On October 23, 2024, Eli Lilly and Company (NYSE: LLY) announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for its drug donanemab. Donanemab is an intravenous infusion medication administered once every four weeks.Approved in the UK for the treatment of adult patients with mild cognitive impairment and mild Alzheimer's disease (AD) who meet the criteria.The UK is another major market to approve donanemab (brand name: Kisunla) for marketing after the US and Japan.
AD is a fatal disease that leads to the gradual decline of memory and other cognitive functions, and is the most common type of dementia, accounting for 60%-80% of all dementia cases.iCurrently, there are over 50 million people with dementia globally, and this number is expected to increase to nearly 152 million by 2050.。 iiIn China, there are currently nearly 10 million AD patients, and this number is expected to reach 40 million by 2050.iiiThe ranking of total deaths caused by dementia in China has risen from tenth place in 1990 to fifth place in 2019.iv
Donanemab is the only amyloid plaque-targeting therapy with evidence supporting that treatment can be stopped after clearing amyloid plaques. Amyloid is a naturally produced protein in the body that can clump together to form amyloid plaques. Excessive accumulation of amyloid plaques in the brain may lead to memory and thinking problems associated with Alzheimer's disease.v,viKisunla can help the body clear excessive accumulation of amyloid plaques and slow down the conditions that may lead to the inability to remember new information, important dates and meetings, plan management, cooking, using household appliances, managing finances, and the decline of independent self-care abilities.iv,v,vii,viii
Previously, donanemab has been granted marketing authorization in the United States, the United Arab Emirates, Japan, and Qatar. In China, donanemab has received the Breakthrough Therapy Designation from the National Medical Products Administration (NMPA) and has been included in the priority review and approval process, currently under evaluation.
About Kisunla™ (donanemab)
Kisunla™ (donanemab) (pronounced kih-SUHN-lah) is a treatment for early symptomatic Alzheimer's disease, including patients with mild cognitive impairment (MCI) or mild dementia with confirmed amyloid pathology. Kisunla may cause serious side effects, including amyloid-related imaging abnormalities or ARIA, and infusion-related reactions. Kisunla is a prescription medicine administered intravenously once every four weeks, with the first three doses at 700 mg followed by 1400 mg.
Lilly
About Eli Lilly and Company
Eli Lilly and Company is a pharmaceutical company dedicated to improving human health through scientific innovation and benefiting patients worldwide. As a leader in the healthcare industry, Eli Lilly and Company has nearly 150 years of history. Today, our medicines have helped tens of millions of people globally. Harnessing the power of biotechnology, chemistry, and genomic medicine, our scientists are actively advancing new medical breakthroughs to address severe global health challenges. Redefining therapies for diabetes and obesity, reducing the long-term impact of obesity on the body; supporting prevention and treatment efforts for Alzheimer's disease; providing solutions for a range of immune-mediated diseases that threaten human health; and transforming difficult-to-treat cancers into manageable conditions. Every step Eli Lilly and Company takes toward a healthier world stems from our belief in "making life better for millions of patients." This includes innovative clinical trials aimed at addressing multiple global challenges while ensuring the accessibility and affordability of medicines. For more information about Eli Lilly and Company, please visit: www.lilly.com.cn.
References
PP-MG-CN-3721