Biogen has also filed protocol to the FDA to start a re-dosing study of aducanumab. Now working with clinical sites and ethics committee to start running trial. Will be open to people previously enrolled in an aducanumab trial to start receiving the drug again.
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Biogen's Al Sandrock says the company is running the aducanumab re-dosing study primarily for humanitarian reasons. "We felt we owed something to them [the patients]. Many of them expressed a desire to the investigators that they wanted the drug," he said
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The re-dosing study will be single arm, so main focus will be safety and tolerability. Sandrock likened it to an open-label extension — but also said they will look at efficacy as best as they can on biomarkers like amyloid.
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Sandrock says Biogen built its Alz. pipeline with combination therapies in mind. He says the most obvious Alzheimer's combination to try is adding an anti-tau to aducanumab
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