Roche (OTCQX: RHHBY) has announced that its investigational anti-amyloid beta antibody gantenerumab for Alzheimer’s disease received breakthrough therapy designation from FDA.
The agency has granted the status to a range of investigational Alzheimer’s, including lecanemab from Eisai and Biogen and donanemab from Eli Lilly. Biogen’s aducanumab had also received the designation before FDA approved it in June.
Clinical trial data has shown that gantenerumab significantly reduced brain amyloid plaque, which accumulates in the brains of people with Alzheimer’s.
The so-called amyloid hypothesis has led to the development of scores of failed experimental Alzheimer’s therapies. Biogen‘s (NSDQ:BIIB) aducanumab was the first to win FDA approval based on amyloid clearing.
Showing convincing evidence of cognitive improvement, however, has remained more elusive for drug developers. A Phase 3 trial of gantenerumab did no…