Lecanemab

EU drugs regulator recommends Leqembi for early-stage Alzheimer's, reversing initial rejection due to brain swelling risks. The endorsement targets patients with specific genetic profiles, potentially influencing drug pricing and reimbursement across EU nations.

Eisai and partners win EU regulator's backing for Alzheimer's drug Leqembi, reversing a previous negative opinion. The drug should be limited to patients with one or no ApoE4 gene variant, linked to higher Alzheimer's risk. Leqembi has already been approved in Japan, China, and the US, with Europe potentially accounting for up to 30% of its worldwide peak sales.

EU drugs regulator recommends approval of Leqembi, an Alzheimer's drug by Eisai and Biogen, for patients with one or no ApoE4 gene variant. If accepted by the European Commission, it could become the first approved Alzheimer's treatment in the EU, with member states deciding on pricing and reimbursement.

The article discusses the importance of enabling JavaScript for optimal app performance.

BioArctic's Q3 2024 report highlights Leqembi's launch in Hong Kong, Israel, UAE, and Great Britain, EMA's negative opinion on lecanemab, and positive lecanemab OLE data. Post-period events include TGA's initial lecanemab rejection, AHEAD 3-45 full recruitment, and Eisai's subcutaneous Leqembi application in the US. Financials show higher royalties, with CEO Gunilla Osswald emphasizing BrainTransporter technology's potential.

EMA's final decision on Leqembi's EU approval imminent after re-examination, with patient representatives set to voice their opinions at a crucial meeting.

Eisai reports 3% Q2 FY2024 revenue growth to JPY 385 billion, driven by a 5% increase in the pharmaceutical segment, led by Lenvima, Dayvigo, and LEQEMBI. Despite a decline in operating profit due to increased SG&A expenses, the company maintains its full-year forecast and announces an interim dividend of JPY 80 per share. LEQEMBI's U.S. launch contributes JPY 16.3 billion in H1 sales, with 10,000 patients ready for treatment, though 6,000 face infusion delays. Eisai focuses on expanding infusion capacity and improving amyloid beta testing efficiency to enhance patient access and future profitability.

Biopharma layoffs continue into 4Q 2024, affecting companies like Thermo Fisher, Charles River, Pfizer, Evonik, Johnson & Johnson, Bayer, Bristol Myers Squibb, AGC Biologics, and others. These layoffs are part of restructuring initiatives, site closures, and focus shifts in strategic core growth areas.

Eisai reports 3% Q2 FY2024 revenue growth to JPY 385 billion, driven by a 5% increase in its pharmaceutical segment. Despite a slight dip in operating profit to JPY 27.8 billion, flagship products like LEQEMBI show promising growth. LEQEMBI sales reach JPY 16.3 billion globally in H1 FY2024, with significant growth in the U.S. and China. The company maintains full-year revenue and profit forecasts and announces an interim dividend of JPY 80 per share. Eisai focuses on cost control and key product growth, with optimism for future market expansion despite infusion capacity constraints delaying treatment for 6,000 patients.

Innovation in neuropsychiatry is reviving after 40 years of dormancy, with recent approvals like Bristol Myers Squibb’s Cobenfy and Sage Therapeutics’ Zurzuave. Large Phase III studies on psychedelics aim to shift from anecdotal to evidence-based treatments. Challenges include high costs of Phase III trials and lack of effective animal models for CNS disorders. Investment in neuroscience is cyclical, with a need for better patient selection and biomarkers. Infrastructure and less intrusive diagnosis methods, like blood-based biomarkers, are crucial for tackling neurodegenerative diseases. AI and analytics advancements could improve diagnostic efficiency and patient targeting, despite regulatory hurdles and mixed public perception in neuropsychiatry.