FDA comes through with greenlight for new Alzheimer's therapy

Having controversially approved the first new Alzheimer’s disease drug Aduhelm (aducanumab) in decades in 2021, dead on schedule, the US Food and Drug Administration on Friday announced its decision on a follow-on product. And it was positive.

The FDA granted accelerated approval for Japanese drugmaker Eisai (TYO: 4523) and US biotech company Biogen’s (Nasdaq: BIIB) Leqembi (lecanemab-irmb) for the treatment of Alzheimer’s. Biogen shares, trading of which had been suspended ahead of the announcement, moved up 4.4% to $282.06. The news came long after Tokyo trading closed.

The approved labelling is much as expected, and encourages treatment initiation only in patients with mild cognitive impairment or mild dementia (similar to enrollment criteria in the trial). The label included warnings and precautions related to amyloid-related imaging abnormalities (ARIA) during the first 14 weeks of treatment, with an increased risk of ARIA in APOE4 homozygotes compared to heterozygotes and noncarriers.