Biogen pulls their European application for Aduhelm
On Friday, April 22nd, 2022, Biogen announced that it had withdrawn the marketing application in the EU for aducanumab (Aduhelm), its monoclonal antibody that targets aggregated forms of amyloid beta found in the brains of Alzheimer’s patients.
Medicare’s Aduhelm NCD Has Implication Outside of Alzheimer’s Disease
As a third installment of our Aduhelm coverage, we look at the recently announced draft National Coverage Determination (NCD) by the Centers for Medicare and Medicaid Services (CMS).
Aduhelm vs. Exondys-51: Understanding the disparity in launch success of two similarly uncertain evidence packages
In June, Windrose’s Elizaveta Tchebaniouk provided an analysis of Aduhelm’s approval in Alzheimer’s Disease (AD) and the dynamic environment surrounding Biogen’s launch in the US. High unmet need, uncertain evidence, modest clinical benefit, and affordability concerns continue to make for a highly complex commercial launch.
Aduhelm Approval Brings Potential for an Evolving Alzheimer’s Disease Treatment Market and Challenges for Healthcare Costs
On June 7th, the FDA granted accelerated approval for Biogen’s amyloid beta-directed anti-body Aduhelm (aducanumab), the first potentially disease-modifying treatment and first approval for Alzheimer’s disease (AD) in nearly two decades.