The USFDA has approved Aducanumab , the very first therapy for the treatment of Alzheimer’s disease. The drug can be used for serious or life-threatening illnesses and can provide a therapeutic advantage over existing treatments. Read on to know more about the approval. Aducanumab is the first-of-its-kind treatment for Alzheimer’s diseases approved by the USFDA since 2003 and the first therapy to target the fundamental pathophysiology of the disease.
The approval is based on the efficacy of the drug assessed in three separate double-blind, randomized, placebo-controlled trials in 3482 participants. The results of the studies were analyzed using a surrogate endpoint of reduction of amyloid-beta plaque in the brain. Quantification of the plaque was done by PET imaging and showed that the levels of the amyloid-beta plaque widely affected the disease pathology. The patients receiving the…
