Tempus AI Study Highlights Benefits of Dual RNA and DNA Sequencing for Advanced Lung Cancer

Ontada and Datavant Partner to Expand Access to Real-World Oncology Data for Accelerated Cancer Innovation

Tempus AI and Flatiron Health Partner to Integrate Genomic Testing into OncoEMR for Enhanced Oncology Care

Flare Therapeutics and Roche Forge Strategic Partnership to Discover Precision Oncology Therapies Targeting Transcription Factors

FDA Approves Autolus’s CAR-T Therapy Aucatzyl for Relapsed or Refractory B-ALL in Adults

Biosimilars: Expanding Access to Precision Medicine through Affordable Biologic Therapies

IDEAYA Biosciences Secures Exclusive Worldwide License for Biocytogen’s BsADC Program IDE034 for Solid Tumor Treatment

Seer and Thermo Fisher Scientific Announce Strategic Collaboration to Advance Proteomics with Integrated Platform Solution

SystImmune Secures FDA Clearance for IND Application of Novel ADC Therapy BL-M17D1 for Advanced Solid Tumors

Medicare Expands Coverage for Adaptive Biotechnologies' clonoSEQ® MRD Test to Include Mantle Cell Lymphoma

Illumina and PHASE Partner to Advance Oncology Testing in the Greater Bay Area, Supporting the "Healthy China" Initiative

MGI Partners with Human Cell Atlas to Advance Global Human Cell Mapping

NHS Wales and Illumina Expand Partnership to Advance Genomic Cancer Detection and Personalized Medicine

Unlocking Genomic Potential for Rare Cancers: Cancer52 and Genomics England’s Collaborative Approach

Tempus AI Launches Immune Profile Score to Enhance Precision in Immunotherapy for Advanced Cancer Patients

Home
/
update
/
details

Lilly's Kisunla™ (donanemab-azbt) Gains Approval in Japan for Early Symptomatic Alzheimer's Disease Treatment

NextEdge Admin

25 Sep 2024

1 min 59 sec

Japan's Ministry of Health has approved Kisunla™ (donanemab-azbt), an Alzheimer's treatment developed by Eli Lilly, for adults with early symptomatic Alzheimer's disease (AD), including mild cognitive impairment and mild dementia stages with confirmed amyloid pathology. Japan, facing a projected 5 million dementia patients by 2030, sees Alzheimer's as the most common cause, accounting for over 67% of cases.

Kisunla, based on Lilly's 35 years of Alzheimer's research, has shown significant cognitive and functional decline reduction in early symptomatic AD patients in the TRAILBLAZER-ALZ 2 study. In this trial, the treatment slowed clinical decline by 35% in participants with low to medium tau protein levels, with a 22% decline reduction in the overall population. The study also demonstrated amyloid plaque clearance of 84% at 18 months.

Kisunla can cause amyloid-related imaging abnormalities (ARIA), detected through MRI scans, and may present as temporary brain swelling or minor bleeding. While most cases resolve, serious or life-threatening conditions can occur. Other side effects include headaches and potential allergic reactions during infusion. However, patients may stop treatment once amyloid plaques are cleared, reducing the infusion burden.

Kisunla represents a critical advance in Alzheimer's treatment, offering patients more time with preserved cognitive and functional abilities.