FDA fast track designation for Biogen’s investigational Alzheimer’s treatment

pharmafile | September 2, 2016 | News story | Medical Communications, Research and Development Alzheimer's, Alzheimer’s, Biogen, FDA, aducanumab, fast track 

Biogen has announced that its investigational Alzheimer’s disease treatment aducanumab has been granted fast track designation by the FDA.

The FDA’s fast track programme supports the development of new treatments of serious conditions for which there are unmet clinical needs.

The drug is in the process of being evaluated for safety and efficacy in slowing cognitive impairment and disability progression in sufferers of the disease through two global Phase III studies.

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Aducanumab is a human recombinant monoclonal antibody (mAb) derived from a de-identified library of B cells collected from healthy elderly subjects with no signs of cognitive impairment or cognitively impaired elderly subjects with unusually slow cognitive decline using Neurimmune’s technology platform called Reverse Translational Medicine (RTM). Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement.

“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,” commented Alfred Sandrock, executive vice president and chief medical officer at Biogen.

 Matt Fellows

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