Aducanumab Principal Investigators
Thank you for your support of the development of aducanumab. We understand that you may have many questions. We will try to answer them below.
- Does Biogen see a correlation between the amount of amyloid that was removed and the degree of clinical benefit?
- The results of the new analysis of the larger dataset demonstrate a time- and dose-dependent reduction of amyloid plaque and a slowing of clinical decline as measured by the pre-specified primary and secondary endpoints.
- This is technically not a correlation analysis.
- What is the study design of the re-dosing study?
- We are working with the goal of setting up the re-dosing study as quickly as possible.
- The details of the study activities are being worked out.
- In principle, eligible patients previously enrolled will have the opportunity to participate in the re-dosing study. The aim is to make the eligibility criteria as inclusive as possible in line with the requirements for the study. There will be no placebo arm so eligible patients will receive aducanumab.
- Why did Biogen do a futility analysis?
- Futility analyses are common in large clinical studies and these analyses help ensure that patients are not unnecessarily exposed to investigational therapies that are unlikely to be effective.
- They use statistical modeling to attempt to predict the outcome of the studies based on a number of pre-specified assumptions and criteria. There are multiple methodologies that can be used for futility analyses, and the methodology we used is a well-accepted approach.
- What did Biogen present at the 12th Clinical Trials on Alzheimer’s Disease (CTAD)?
- On December 5, 2019, Biogen presented additional details from EMERGE and ENGAGE, two global Phase 3 studies for aducanumab at the 12th Clinical Trials on Alzheimer’s Disease (CTAD) Congress in San Diego, CA. During this presentation, Biogen shared the topline data on the primary and secondary clinical endpoints based on the pre-specified statistical analysis plan, as well as data from disease biomarker sub-studies, including amyloid PET, tau PET and tau CSF biomarkers. Furthermore, we presented patient demographic characteristics and safety results from each study. LEARN MORE
- When will I hear more?
- We are now moving forward on the ground of positive clinical results, in consultation with the FDA, with a sense of urgency as we feel a deep responsibility to bring this potential treatment to patients as soon as possible.
- We are finalizing the details of a re-dosing study with the aim to offer access to aducanumab to eligible patients previously enrolled in the aducanumab clinical studies. We know timing is critical and we will work with regulatory authorities and principal investigators with a sense of urgency.