The biotechnology company Biogen has recently received approval from the US Food and Drug Administration (FDA) to re-dose the research participants formerly enrolled in its ENGAGE and EMERGE Phase III studies of Aducanumab in Alzheimer’s disease (AD).
Around 2,400 participants are eligible to participate in the new Phase III study expected to start in March 2020. This Phase IIIb trial is an open-label and multicentre study evaluating the safety and tolerability of Aducanumab in US participants with AD who had previously participated in the Aducanumab studies. In this new trial, all participants will receive monthly intravenous infusions of Aducanumab (10mg/kg) for a total duration of 100 weeks.
The EMERGE and ENGAGE Phase III studies were discontinued in March 2019 following a futility analysis of data, which reported that the trials were unlikely to meet their primary endpoint. As a result of this decision, the EVOLVE Phase II safety study and the PRIME Phase Ib long-term extension study of Aducanumab were also discontinued. However, in October, Biogen announced its plans to seek regulatory approval for Aducanumab, based on a new analysis of a larger dataset from its EMERGE and ENGAGE Phase III studies. The new analysis revealed that the Phase III EMERGE study had met its primary endpoint, showing a significant reduction in clinical decline following administration of Aducanumab to participants with mild cognitive impairment due to AD and mild AD dementia.
https://www.beingpatient.com/fda-approves-aducanumab-redosing-trial/
