According to an article in the Alzheimer’s publication Being Patient, participants who had been enrolled in the discontinued phase three trials of aducanumab will start receiving the drug as early as March of this year as the first step in the FDA approved the re-dosing study.
Biogen Discontinued Aducanumab
Biogen and partner Eisai issued a statement about a year ago that it was terminating their phase three trials of aducanumab on the basis of the drug failing “futility tests.” Their opinion was that the drug would not be an effective treatment for Alzheimer’s disease.
Biogen Resubmitted Its Application
In October 2019 Biogen announced that it had been performing continuous data analysis. The company discovered that the drug indeed demonstrated significant benefits for people who have mild cognitive impairment or early Alzheimer’s disease. Patients in these categories were given a larger dose of the drug for an increased period of time.
Biogen’s analysis showed a substantial slowing of the disease. Patients who took the drug as prescribed improved in performance of daily activities such as household chores, shopping, and independence when leaving their homes.
Biogen is, therefore, seeking approval from the FDA to market aducanumab.
Restarting the Process
Biogen emailed Being Patient explaining that it is working with various clinical trial sites in the U.S. in order to begin a new trial for the patients who had been enrolled in the previous aducanumab studies.
While it was waiting for FDA approval Biogen began to offer aducanumab to the nearly 2400 international participants from the previous clinical trial.
Aducanumab is a human monoclonal antibody that targets amyloid build-up in the brain. Amyloid is believed to be the cause of Alzheimer’s disease. Aducanumab has the potential to prove that the removal of amyloid in the brain has an impact on Alzheimer’s disease.
About the New Study
All 2400 subjects who had been enrolled in the clinical trials in March of 2019 will be eligible for the new trial.
Participants will receive aducanumab in a 10mg/kg IV dose for one hundred weeks. None of the subjects will receive a placebo.
Biogen announced that it will also apply to institutional review boards and regional regulators in Japan and Europe for approval of the new trial.
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