Aducanumab produced a clinically meaningful benefit in association with amyloid lowering.
Aducanumab is a monoclonal antibody targeting amyloid beta protein, a defining feature of the biology of Alzheimer’s disease. Laboratory studies showed high affinity of aducanumab for the neurotoxic oligomeric species. Following a promising phase 1B trial, the sponsor (Biogen) implemented two phase 3 studies—EMERGE and ENGAGE.
CMS made the wrong decision on Aduhelm. But there might be a silver lining.
The Centers for Medicare and Medicaid Services (CMS) issued on Thursday its hotly debated final decision on whether to cover aducanumab (Aduhelm), the first FDA-approved treatment for Alzheimer’s that slows the disease’s biological progression rather than just temporarily easing its symptoms. We believe it made the wrong choice.
LECANEMAB® Study Showing Highly Significant Reduction Of Clinical Decline In Participants With Early Alzheimer’s Disease
LECANEMAB® Confirmatory Phase 3 Clarity Ad Study Met Primary Endpoint, Showing Highly Statistically Significant Reduction Of Clinical Decline In Large Global Clinical Study Of 1,795 Participants With Early Alzheimer’s Disease
ADUHELM® Continues to Reduce Underlying Pathologies of Alzheimer’s Disease
Long-Term Phase 3 Data Show ADUHELM® Continues to Reduce Underlying Pathologies of Alzheimer’s Disease in Patients Treated for More Than Two Years