Eisai Initiates Rolling Submission of BLA to the US FDA for Lecanemab to Treat Alzheimer’s Disease

September 28, 2021 Auto Bot BLA, Eisai, FDA, lecanemab, regulatory 0

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

Click here to­ read full press release/ article | Ref: PR Newswire | Image: Telangana Today

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