相关临床试验
6
3 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
1992
进行中（未招募）
3
50.0%
已完成
2
33.3%
招募中
1
16.7%
暂无批准数据
- Eisai and Biogen announced Japan's approval of LEQEMBI Pen, a subcutaneous autoinjector formulation of lecanemab, as a new route of administration for early Alzheimer's disease. - The approval makes Japan the third country globally to clear the subcutaneous formulation, following the United States in July 2026 and China in September 2026. - Two pens totaling 500 mg are given once weekly, with each injection taking about 15 seconds and demonstrating exposure similar to biweekly intravenous dosing. - Systemic injection-related reactions occurred less frequently with subcutaneous administration at 1.4% compared with intravenous administration, with ARIA monitoring by MRI unchanged.
- BioArctic and Eli Lilly have entered a research collaboration combining BioArctic's BrainTransporter technology with an undisclosed Lilly neurodegeneration drug candidate. - BioArctic will receive a $30 million upfront payment and is eligible for up to $770 million in milestone payments plus tiered mid-single-digit royalties on future sales. - The BrainTransporter platform uses the transferrin receptor to actively transport biologics across the blood-brain barrier, potentially improving efficacy and safety. - This marks BioArctic's fourth BrainTransporter partnership, following prior agreements with Eisai, Bristol Myers Squibb, and Novartis.
- Regulatory authorities in Spain and Poland have approved the inclusion of Multiple System Atrophy (MSA) patients in BioArctic's ongoing EXIST Phase 2a trial of exidavnemab, an alpha-synuclein antibody. - The expanded trial will recruit 12 MSA patients in addition to the 24 participants with Parkinson's disease, evaluating safety, tolerability, and biomarkers in plasma, cerebrospinal fluid, and through digital measurements. - MSA is a rapidly progressive, fatal rare disease with no current treatments to slow progression, affecting fewer than 42,000 people in the U.S. with patients typically surviving only 6-10 years after symptom onset.
- The European Medicines Agency's advisory panel has reversed its initial negative decision and now supports the use of Eisai's Leqembi for treating Alzheimer's disease. - Leqembi's use will be restricted to patients with one or no copy of the ApoE4 gene variant due to the increased risk of brain swelling and bleeding in those with two copies. - This decision marks a significant win for Eisai and its partners Biogen and BioArctic, potentially benefiting millions of Alzheimer's patients in Europe. - Leqembi has already been approved in the US, Japan, and China, and this EU backing could account for up to 30% of the drug's worldwide peak sales.
• Three-year data reveals that lecanemab continues to provide increased patient benefit for individuals with early Alzheimer's disease, showing approximately a 1-point expansion on the CDR-SB scale compared to the ADNI population. • A subset of patients with low levels of brain amyloid at the start of lecanemab treatment demonstrated improved or maintained cognition and function after three years, suggesting early intervention benefits. • Continued lecanemab treatment showed no new safety concerns, with most ARIA events occurring in the first six months and decreasing thereafter, indicating a manageable long-term safety profile. • Data suggest that Alzheimer's disease progression continues even after plaque clearance, supporting the need for continued treatment with lecanemab to prevent amyloid reaccumulation and worsening of plasma biomarkers.
