Today the Food and Drug Administration (FDA) approved a biologics license application (BLA) for Aduhelm (aducanumab; Biogen) for the treatment of Alzheimer disease.
Aduhelm is an amyloid beta-directed antibody that is administered via intravenous infusion every 4 weeks. FDA approval was supported by data from 3 separate studies representing a total of 3482 Alzheimer patients, which demonstrated that patients receiving Aduhelm had significant dose-and time-dependent reduction of amyloid beta plaque; patients in the control arm of the studies had no reduction of amyloid beta plaque.
This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with Aduhelm. Under the accelerated approval provisions, the FDA is requiring the company to conduct a new randomized controlled clinical trial to verify the drug’s clinical benefit. If the trial fails to verify clinical benefit, the FDA may initiate proceedings to withdraw approval of the drug.
Food and Drug Administration (FDA). FDA Grants Accelerated Approval for Alzheimer’s Drug [news release] June 7, 2020. Available at: click here. Accessed June 7, 2020.