The professor of Molecular Neuroscience at the Edmond and Lily Safra Center for Brain Sciences discussed her and her colleague’s initial response to the FDA’s approval of aducanumab.
"Anything that can be done [to treat AD should] be received with appreciation. There will be a lot of pressure on the regulatory governments to facilitate the use of this such treatment.”
On June 7, 2021, the FDA approved aducanumab (Aduhelm; Biogen), an anti-amyloid, disease modifying therapy for the treatment of Alzheimer disease, the first approval for the neurodegenerative condition since 2003. The therapy was approved under the Accelerated Approval pathway, which requires Biogen to conduct post-approval phase 4 studies to confirm the benefit of the drug.
The monumental decision came with a range of opinions from clinicians, including those who believed the drug should have not been approved based on the supporting data included in the filing. Some also noted that there could be severe and lasting effects on the standardization of FDA approvals for the disease, suggesting it may have lowered the bar for approval, while others pointed to aducanumab being the first drug in the anti-amyloid class as a potential door-opening moment.
Hermona Soreq, PhD, professor of Molecular Neuroscience, Edmond and Lily Safra Center of Brain Sciences, Hebrew University of Jerusalem, was surprised by the decision but expressed belief that it is a great step forward. She sat down with NeurologyLive to provide her own perspective, as well as to share how the general international community has perceived the decision.