FDA Tightens Safety Guidelines For Biogen Leqembi Alzheimer's Therapy

The U.S. Food and Drug Administration (FDA) stated on Thursday that it is requiring an additional MRI scan for Alzheimer's patients receiving Leqembi (lecanemab), citing safety concerns over a rare but potentially fatal side effect.

Biogen Inc.’s (NASDAQ:BIIB) Leqembi, developed to slow the progression of Alzheimer's disease in patients with mild cognitive impairment or early-stage dementia, received FDA approval in 2023.

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The antibody therapy targets beta-amyloid plaques, protein deposits in the brain linked to the disease's progression.

By reducing these plaques, the drug aims to preserve ...