FDA 'Breakthrough' status for Lilly's Alzheimer's candidate

25 June 2021

After a dearth of advances on the treatment of Alzheimer’s disease for many years, June has become the month of action, with conditional US regulatory approval for the first treatment in 20 years, and two investigational drugs gaining Breakthrough status.

The latest news yesterday saw the US Food and Drug Administration grant Breakthrough Therapy designation (BTD) for donanemab, US pharma major Eli Lilly’s (NYSE: LLY) investigational antibody therapy for Alzheimer's disease (AD).

Lilly’s shares closed up 7.3% at $232.97 yesterday following the announcement, which came just a day after Biogen (Nasdaq: BIIB) and Eisai (TYO: 4523) were granted BTD for their AD candidate lecanemab (BAN2401).

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