Mankind Pharma and Innovent Biologics Partner to Launch Groundbreaking PD-1 Immunotherapy in India

Duchenne Muscular Dystrophy: Diagnosis, Treatment, and Emerging Therapies

Ikena Oncology and Inmagene Biopharmaceuticals Announce Merger to Form ImageneBio

Fujirebio and Eisai Partner to Advance Diagnostics for Neurodegenerative Diseases

European Commission Approves Opdivo® Plus Yervoy® for First-Line Treatment of MSI-H or dMMR mCRC

Deerfield Management to Acquire Singular Genomics for $20 Per Share in All-Cash Deal

EU Approval of Tagrisso Sets New Standard for EGFR-Mutated NSCLC Treatment

Aurobindo Pharma’s Subsidiary CuraTeQ Secures UK Approval for Bevacizumab Biosimilar

SCG Cell Therapy Partners with A*STAR BTI and NATi to Advance RNA-Based Therapeutics

Korea's National Bio Big Data Project: Advancing Precision Medicine with Macrogen and Illumina

GST Exemption Announced for Cancer Treatment Gene Therapy

AIIMS Develops Affordable CAR-T Cell Therapy for Multiple Myeloma

Sangamo Therapeutics and Astellas Collaborate on Innovative Gene Therapy for Neurological Diseases

FDA Clears IND for Arbor Biotechnologies’ ABO-101 Gene Editing Therapeutic for Primary Hyperoxaluria Type 1

Fortis Healthcare Acquires Stake in Agilus Diagnostics

Home
/
update
/
details

Leqembi Approved for Alzheimer's Treatment in Hong Kong

NextEdge Admin

11 Jul 2024

2 min 19 sec

Eisai and BioArctic AB (NASDAQ Stockholm: BIOA B) have secured approval from Hong Kong's Department of Health for Leqembi® (known locally as "樂意保®", generic name: lecanemab) to treat Alzheimer's disease (AD), marking its fifth global approval after the US, Japan, China, and South Korea. Leqembi is designated for patients with mild cognitive impairment (MCI) or mild dementia, consistent with its successful outcomes in the Phase 3 Clarity AD study.

In Hong Kong, where a significant proportion of the elderly population faces AD challenges, Leqembi's approval is based on its efficacy in targeting soluble and insoluble amyloid-beta (Aβ) aggregates in the brain, notably protofibrils and fibrils. This mechanism is pivotal in reducing Aβ plaques and thereby slowing cognitive decline, validated through rigorous clinical trials.

The collaboration between BioArctic and Eisai, stemming from BioArctic's discovery of the Arctic mutation in AD, has facilitated Leqembi's development. Eisai leads clinical development, regulatory submissions, and global commercialization efforts, with BioArctic entitled to milestone payments, sales royalties, and potential commercialization rights in the Nordic region, pending EU approval.

Eisai has also initiated applications for Leqembi in the EU and is exploring broader therapeutic applications through ongoing trials such as AHEAD 3-45 for preclinical AD and Tau NexGen for Dominantly Inherited AD. BioArctic, focusing on neurodegenerative diseases, expands beyond Leqembi with innovations like BrainTransporter™ to improve treatment efficacy, underscoring its commitment to advancing therapies for Alzheimer's, Parkinson's, and ALS.