Shots:

• The submission is based on clinical- biomarker & safety data of Study 201 POC study evaluates lecanemab (10mg/kg- q2w) in 856 patients with MCI due to AD with confirmed presence of amyloid pathology. The BLA is being submitted under accelerated approval
• The results showed a reduction in brain amyloid by 0.306 SUVr units @18mos. of treatment & clinical decline across several clinical EPs- >80% of subjects achieved amyloid negative status by visual read @12mos.- 9.9% rate of ARIA-E
• Additionally- amyloid reduction in the Core period was maintained while off-treatment over Gap period & a rate of ARIA-E was consistent with a Core study at ~10%. The P-III Clarity AD trial in early AD is ongoing

  | Ref: PR Newswire | Image: Telangana Today