Shots:

• The FDA’s BT designation is based on results from P-IIb Study 201 trial evaluates lecanemab in 856 patients with MCI due to AD and mild AD with confirmed presence of amyloid pathology
• The pre-specified analysis showed a consistent reduction of clinical decline across several clinical & biomarker EPs at highest dose while OLE data showed a time-dependent reduction of brain Aβ
• In Mar- companies have completed the enrolment in Clarity AD study for lecanemab in 1795 patients with early AD & 1EP of study is expected to complete at end of Sept’22. The therapy is currently evaluating in P-III AHEAD 3-45 study for preclinical AD

  | Ref: Biogen | Image: Biogen