Biogen’s investigational treatment Aducanumab for early Alzheimer’s disease (AD) has secured fast-track designation from the US Food and Drug Administration (FDA).
The programme will support the development of new treatments for serious conditions with an unmet medical need such as Alzheimer’s.
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Biogen executive vice-president and chief medical officer Alfred Sandrock said: “By collaborating with regulators through programmes such as Fast Track, we hope to bring effective treatments to patients and families affected by Alzheimer’s disease (AD) as quickly as possible.”
At present, the treatment is being evaluated in two global Phase III studies, Engage and Emerge, which are designed to evaluate its safety in slowing cognitive impairment and the progression of disability in people with this disease.
The ongoing Phase Ib randomised, double-blind, placebo-controlled, multiple-dose Prime study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical effects of aducanumab in patients with prodromal or mild AD.
Aducanumab (BIIB037) is an investigational compound being developed to treat early AD.
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By GlobalDataThis human-recombinant monoclonal antibody (mAb) is believed to target aggregated forms of beta amyloid, including soluble oligomers and insoluble fibrils deposited into the amyloid plaque in the brain of AD patients.
AD is a progressive neurodegenerative disorder characterised by cognitive decline and behavioural disturbances that ultimately result in a person’s inability to perform daily activities.
