FDA Greenlights Novel Alzheimer’s Drug

In a groundbreaking decision, the FDA has granted full approval to Leqembi (lecanemab), a novel drug developed by Eisai and Biogen to treat Alzheimer’s disease. This milestone marks a significant turning point in the field of Alzheimer’s disease research, as Leqembi becomes the first drug of its class to receive traditional approval.

Alzheimer’s disease, the most common form of dementia, is characterized by the accumulation of misfolded amyloid beta protein in the brain. Over time, these abnormal proteins aggregate to form plaques, which in combination with the misfolded tau protein, gradually damage brain tissue, causing cognitive decline and memory loss.

Leqembi is an antibody-based drug that specifically targets amyloid beta by breaking down existing plaques and inhibiting the formation of new ones. This approach represents a novel therapeutic strategy, aiming to halt or slow down cognitive decline in individuals with Alzheimer’s. This drug approval follows the encouraging phase 3 results from the Clarity AD trial, where it demonstrated a 27% reduction in cognitive decline among patients with early-stage Alzheimer's compared to placebo over an 18-month period.

The recent approval of Leqembi holds immense promise to individuals and families impacted by Alzheimer’s. As Canada awaits its own regulatory decision following the submission for approval in May, the anticipation for improved outcomes in treating the disease continues to grow.

Written by Brienne Stairs, MSc