FDA grants Breakthrough Therapy Designation (BTD) for an investigational anti-amyloid beta protofibril antibody, lecanemab, for treatment of Alzheimer's disease (AZ)

BTD was based on data from phase 2b trial (n=856) which suggests treatment reduces clinical decline across several clinical and biomarker endpoints at the highest doses in patients with mild cognitive impairment due to AZ and mild AZ with confirmed presence of amyloid pathology.

Biospace Inc.