ARTICLE | Product Development

Clinical trials in neurodegeneration start a new page following aducanumab approval

Biomarkers take center stage, and a new background therapy needs to be factored in

June 12, 2021 3:14 AM UTC

Biopharma executives in the Alzheimer’s field are delighted with FDA’s decision to grant accelerated approval to Biogen’s aducanumab. As the first biomarker-based approval for a neurodegenerative disease, the move cracks the door open to a shorter development path for everyone.

Though it will take time for additional biomarkers to be ready for use as surrogate endpoints, seven executives working in the Alzheimer’s field told BioCentury they are confident FDA’s approval of Aduhelm aducanumab from Biogen Inc. (NASDAQ:BIIB) marks a turning point for drug development in Alzheimer's and in neurodegeneration broadly. ...