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Eisai and Biogen announced that LEQEMBI® (lecanemab) has received approval from Mexico's COFEPRIS for the treatment of early Alzheimer's disease (AD). LEQEMBI is the first approved treatment demonstrated to reduce disease progression rate and slow cognitive decline by targeting soluble Aβ aggregates and reducing both Aβ protofibrils and plaques in the brain.

The approval is supported by the global Phase 3 Clarity AD study, which met its primary and key secondary endpoints with statistically significant results. Mexico has approximately 1.3 million people affected by AD, representing 60-70% of all dementia cases. LEQEMBI is already approved and marketed in several countries including the U.S., Japan, China, and others.

Eisai and Biogen have launched LEQEMBI® in South Korea following its approval by the Ministry of Food and Drug Safety in May 2024. The drug is approved for treating adult patients with mild cognitive impairment due to Alzheimer's disease (AD) or mild AD dementia. LEQEMBI is the first approved treatment that reduces disease progression by targeting soluble and insoluble Aβ aggregates in the brain.

South Korea has approximately 900,000 dementia patients, with AD accounting for 70% of cases. The average annual care costs per dementia patient are estimated at 21.1 million South Korean Won, rising to 33.1 million Won for severe cases. Eisai Korea Inc. will handle distribution and launch the drug in the private market, including establishing a Patient Assistance Program.

Biogen (BIIB) and UCB presented Phase 3 PHOENYCS GO study results for dapirolizumab pegol (DZP) in systemic lupus erythematosus (SLE). The study met its primary endpoint with DZP showing a 14.6% higher response rate (49.5%) compared to standard of care (34.6%). Key secondary endpoints demonstrated significant improvements, including 50% fewer severe disease flares and 17.1% more participants achieving corticosteroid dose reduction. The safety profile was generally favorable, with 82.6% of DZP patients experiencing treatment-emergent adverse events versus 75% in the control group. A second Phase 3 trial, PHOENYCS FLY, will be initiated in 2024.

Eisai and Biogen received a positive opinion from the European Medicines Agency's CHMP for lecanemab, recommending its approval for treating early Alzheimer's disease in adult patients with specific genetic profiles. This follows a re-examination of a previous negative opinion from July 2024. The treatment targets amyloid-beta aggregates in the brain, potentially slowing disease progression. The European Commission's final decision is expected within 67 days. Alzheimer's disease affects approximately 6.9 million people in Europe, with numbers projected to double by 2050.

Eisai and Biogen received a positive opinion from the European Medicines Agency's CHMP for lecanemab in treating early Alzheimer's disease. The treatment is recommended for adult patients with mild cognitive impairment and mild dementia due to Alzheimer's, specifically for ApoE ε4 non-carriers or heterozygotes with confirmed amyloid pathology. The European Commission's final decision is expected within 67 days. In clinical trials, lecanemab showed a 31% reduction in clinical decline compared to placebo at 18 months, and demonstrated a 33% less decline in daily living activities. The drug is already approved in several countries including the U.S., Japan, and China.

Eisai has completed a rolling Biologics License Application (BLA) submission to the FDA for LEQEMBI® subcutaneous autoinjector for weekly maintenance dosing in early Alzheimer's disease treatment. The submission, under Fast Track designation, is based on data from the Clarity AD open-label extension study. If approved, patients could self-administer LEQEMBI at home in approximately 15 seconds after completing the initial biweekly intravenous phase. The autoinjector option aims to maintain effective drug concentrations while offering greater convenience compared to IV administration.

Eisai and Biogen presented new findings for lecanemab-irmb (LEQEMBI), their Alzheimer's disease treatment, at the CTAD Conference. Three-year continuous treatment data showed significant benefits: 59% of patients with no/low tau accumulation showed improvement or no decline, while 46% of patients with low amyloid levels improved or had no decline on cognitive scales. A new testing method revealed strong correlation between protofibrils and neurodegenerative biomarkers. Long-term safety profile remained consistent with no new concerns, with most ARIA events occurring in the first six months of treatment.

Biogen (BIIB) and Neomorph have announced a research collaboration to develop molecular glue degraders for Alzheimer's, rare neurological, and immunological diseases. The partnership combines Neomorph's molecular glue discovery platform with Biogen's expertise in disease research and drug development. Under the agreement, Neomorph will receive an upfront payment and is eligible for milestone payments totaling up to $1.45 billion, plus potential royalties ranging from mid-single digit to low double-digit percentages. The collaboration aims to identify and validate small molecule therapeutic molecular glue degraders for high-priority targets, with Biogen leading the clinical development and commercialization efforts.

Biogen has appointed Daniel Quirk, MD as Chief Medical Officer and Head of Medical Affairs, effective October 28, 2024. Dr. Quirk will report to Priya Singhal, Head of Development. Previously, he served as Senior Vice President of Worldwide Medical Affairs for Immunology and Neuroscience at Bristol-Myers Squibb, and held leadership positions at Pfizer. Dr. Quirk's background includes medical practice as Associate Chief of Gastroenterology at Thomas Jefferson University Health Systems, with degrees from Brown University (MD), Harvard School of Public Health (MPH), and Wharton School (MBA).