FDA Approves Biogen’s Lecanemab

 Neuroscience pioneer, Biogen, Inc. (Nasdaq: BIIB) has received FDA approval for lecanemab for the treatment of Alzheimer’s disease (AD).

The FDA’s accelerated approval is based on Phase 2 data showing a reduction in amyloid-beta plaques in early AD patients treated with lecanemab.

 Highlights 

• Lecanemab is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta (Aβ) for the treatment of AD.
• The FDA’s approval is based on Biogen’s Phase 2 data demonstrating that lecanemab reduced the accumulation of Aβ plaque in the brain.
• Lecanemab is approved for use in patients with mild cognitive impairment or mild dementia stage of disease.
• The drug has been evaluated in 763 patients with adverse reactions including infusion-related reactions, headache and ARIA-E.
• Lecanemab’s brand name in the United States will be LEQEMBI™.

LEQEMBI will be available during or before the week of January 23, 2023.