Potential Alzheimer’s Treatment, Now in Phase 3 Testing, Gets Boost from FDA

Potential Alzheimer’s Treatment, Now in Phase 3 Testing, Gets Boost from FDA
Aducanumab, an amyloid-fighting medication being developed by Biogen for Alzheimer's disease (AD), has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA). The treatment is currently being evaluated in two large-scale Phase 3 trials, both of which are recruiting Alzheimer's patients. The FDA’s fast track program allows for faster approval of medications for serious conditions that are not adequately treated, such as AD. “By collaborating with regulators through programs like Fast Track, we hope to bring effective treatments to patients and families affected by Alzheimer’s disease as quickly as possible,” Alfred Sandrock, MD, PhD, executive vice president and chief medical officer at Biogen, said in a press release. Aducanumab is thought to block beta-amyloid from sticking together in what are known as plaques, stopping the toxic protein from forming cell-killing deposits in the brains of people with AD. Based on animal studies and initial brain imaging data in humans, aducanumab seems to reduce amyloid plaques. Two global studies, ENGAGE (NCT02477800) and EMERGE (NCT02484547), are now in progress. The trials are evaluating the safety and effectiveness of aducanumab  in delaying cognitive impairment and disability in people with early AD. Anyone interested in learning more about these Phase 3 trials — taking place across the U.S., Canada, Europe and elsewhere — can do so
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