The FDA Has Approved the First New Alzheimer's Disease Treatment in 20 Years
Big news for patients and families affected by Alzheimer's Disease with the FDA approving the first new treatment in 20 years. Biogen's Aducnaumab, a monoclonal antibody, targets amyloid beta plaques in the brain which are thought to be a key driver of pathology and a hallmark of the disease. The drug is not, however, without controversy - clinical trial results were uncertain and were halted early when initial analysis showed the drug was no better at slowing deterioration of memory and cognitive function than a placebo. However, following further data analysis Biogen concluded the drug did in fact work and that clearance of amyloid was likely to slow cognitive decline. A condition of the accelerated approval is the confirmation of efficacy through another clinical trial - however with 9 years to conduct this confirmatory trial important questions around efficacy in a broad patient pool are likely to remain unanswered for some time. With 30 million people globally affected by Alzheimer's disease the approval of a new therapy offers hope to many, especially after the failure of hundreds of therapeutic candidates over the past decade. It is possible that identification of patients with pre-symptomatic disease through screening with serum biomarkers like neurofilament-light, phospho-Tau (pTau) 181, 231 and 217 using next-gen ultrasensitive Quanterix Simoa technologies may provide even greater benefit and prevent symptomatic disease. We look forward to the results Biogen's confirmatory trial as well as phase 3 trials of Sumifilam, a small molecule drug designed to restore normal shape and function of misfolded filament A in Alzheimer's patients. 2021 is shaping up as the best year in 2 decades for a global patient population desperate for good news. Fingers crossed.