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Eli Lilly and Company announced that the European Commission (EC) has granted marketing authorization for Kisunla (donanemab) for the treatment of early symptomatic Alzheimer's disease (AD), in adults with mild cognitive impairment as well as those with mild dementia stages of AD with confirmed amyloid pathology who are apolipoprotein E (ApoE4) heterozygotes or non-carriers.
"Kisunla demonstrated meaningful results in people with early symptomatic Alzheimer's disease by significantly slowing cognitive and functional decline in our phase 3 TRAILBLAZER-ALZ 2 study," said Patrik Jonsson, executive vice president and president of Lilly International. "The data shows that the earlier patients are identified, diagnosed, and treated with Kisunla, the greater the response to treatment. This authorization brings a new option to patients in Europe—offering hope and the potential for more time to focus on what matters most."
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. 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.
Kisunla is the only once-monthly amyloid plaque-targeting therapy with evidence supporting completing course of treatment once amyloid is reduced to minimal levels. This may reduce infusion burden and treatment costs. Treatment with Kisunla slows disease progression which may help preserve cognitive function and independence longer. Data has also shown that Kisunla can significantly reduce the risk of progressing to the next clinical stage of disease over 18 months.
Alzheimer's disease currently affects as many as 6.9 million people in Europe, with this figure expected to almost double by 2050 as aging populations continue to increase. Alzheimer's disease progresses in stages that increase in severity over time, resulting in loss of independence and ability to care for oneself. There is an urgent need for detection, referral to specialists, diagnosis and treatment at the earliest stages of Alzheimer's disease as approximately one-third of individuals in early symptomatic stages of the disease will progress to more advanced clinical stages within one year.
The Kisunla marketing authorization in the European Union is based on the TRAILBLAZER-ALZ 2 and the TRAILBLAZER-ALZ 6 clinical trials. The phase 3 TRAILBLAZER-ALZ 2 study demonstrated Kisunla significantly slowed cognitive and functional decline. Cognitive and functional decline involves greater memory and thinking problems, affecting daily activities and needing more caregiver support.
Amyloid-related imaging abnormalities (ARIA) with edema/effusion (ARIA-E) and with hemorrhage/ hemosiderosis (ARIA-H) are side effects within the class of therapies that do not usually cause any symptoms, but serious and life-threatening symptoms can occur. ARIA can be fatal. Carriers of one or two copies of the ApoE4 gene may be at higher risk of developing Alzheimer's disease and experiencing ARIA. Patients should discuss any safety concerns with their healthcare providers.
The dosing schedule is based on the phase 3b TRAILBLAZER-ALZ 6 study, which demonstrated that the incidence of ARIA-E was significantly lowered at 24 and 52 weeks using a more gradual titration dosing schedule versus the dosing schedule used in TRAILBLAZER-ALZ 2. This gradual dosing increase still achieved similar levels of amyloid plaque removal and P-tau217 reduction.
Donanemab, a monthly infusion, is currently marketed as Kisunla in the United States and other countries, including Japan, China, United Kingdom, UAE, Qatar, Kuwait, Bahrain, Singapore, Taiwan, Brazil, Mexico and Australia. In the United States, Japan, China and many other countries, donanemab is approved for patients regardless of ApoE4 status. In the European Union, Kisunla is approved for patients who are ApoE4 heterozygotes or non-carriers. Donanemab is the first and only amyloid plaque-targeting therapy with evidence supporting completing the course of treatment when amyloid plaques are removed to minimal levels, which can result in lower treatment costs and fewer infusions.
TRAILBLAZER-ALZ 2 (NCT04437511) was a phase 3, double-blind, placebo-controlled study to evaluate the safety and efficacy of donanemab over 18 months in participants with early symptomatic Alzheimer's disease (mild cognitive impairment 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).
TRAILBLAZER-ALZ 6 (NCT05738486) was a phase 3b, multicenter, randomized, double-blind study to investigate different dosing regimens and their effect on ARIA-E in adults with early symptomatic Alzheimer's disease. The trial enrolled 843 participants ages 60-85 selected based on cognitive assessments in conjunction with amyloid plaque imaging by PET scan. The primary endpoint results were published in Alzheimer's and Dementia.
Lilly continues to study donanemab in multiple clinical trials, including TRAILBLAZER-ALZ 3, which is evaluating the safety and efficacy of donanemab in patients with preclinical Alzheimer's disease (Stage 1 and 2) to determine if it reduces risk of progression to symptomatic Alzheimer's disease. TRAILBLAZER-ALZ 5 is a registration trial for early symptomatic Alzheimer's disease currently enrolling in China, Korea, Taiwan, and other geographies.
Lilly is a medicine company turning science into healing to make life better for people around the world. The company have been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe.
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