BioArctic AB

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 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.

• 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.