Lecanemab

EU regulators initially rejected Leqembi, an anti-amyloid drug for Alzheimer's, due to side effects like brain swelling and bleeding. Eisai requested a re-evaluation, leading the EMA to recommend approval for patients with one or zero copies of the ApoE4 gene, where benefits outweigh risks. The decision now awaits finalization by the European Commission.

The FDA granted icometrix clearance for icobrain aria, the first AI software to detect, measure, and grade amyloid-related imaging abnormalities (ARIA), a side effect of amyloid-targeting therapies for Alzheimer’s disease. icobrain aria significantly improves ARIA assessment accuracy, enhancing patient safety and facilitating the wider use of these therapies.

Needham downgrades Biogen, projecting flat revenue until 2026 due to slow growth of Alzheimer’s drug Leqembi and high market expectations. Leqembi's Q3 sales were $67 million globally, $39 million in the U.S. CHMP recommended approval for early Alzheimer’s disease. Skyclarys Q4 sales expected at $116 million, $608 million in 2025. Revenues to remain flat or decline slightly until 2026. Zurzuvae sales reached $22 million in Q3. Needham downgrades stock from Buy to Hold.

New Alzheimer's therapies like Kisunla and Leqembi face regulatory and access challenges, highlighting the need for balancing clinical rigor with patient convenience. Decentralised trials (DCTs) are crucial for Alzheimer's research, though their use has declined, with Eli Lilly leading in DCT adoption. Digital health technologies, including telemedicine and wearables, offer potential to enhance trial data quality and patient recruitment, but challenges remain in ensuring technology usability and data integrity.

icometrix's icobrain aria, the first AI software approved by the FDA for detecting and grading ARIA, enhances ARIA assessment accuracy, ensuring safer use of amyloid-targeting therapies for Alzheimer’s disease. This approval marks a significant advancement in Alzheimer’s care, providing physicians with a tool to make informed treatment decisions and improve patient safety.

The EU approves Leqembi, a drug to delay Alzheimer's onset, for patients not in advanced stages, despite initial rejection due to risk of brain bleeding. The UK also approved it under the name lecanemab, with a controlled availability program to manage risks.

Lecanemab/Leqembi, a slowing agent for dementia, is approved by EMA but only benefits less than 10% of dementia patients, particularly those with early-stage Alzheimer's without other health issues. Alzheimer Nederland calls for a fast track for its use in the Netherlands to reduce patient uncertainty.

Recent advancements in Alzheimer’s treatment include a $74.5 million NIH grant for Banner Alzheimer's Institute to study genetic mutations, focusing on the PSEN1 E280A mutation in Colombian families, and the EMA approval of lecanemab (Leqembi) in Great Britain, which targets amyloid protein buildup. Both developments aim to improve Alzheimer’s care through genetic research and pharmacological advancements.