Biotechnology company Biogen have announced their plans to file for US market approval (FDA) of the potential Alzheimer’s drug, aducanumab (EMERGE and ENGAGE).
Aducanumab is an antibody designed to target the amyloid protein that builds up in the early stage of Alzheimer’s disease. This follows the decision to stop the Phase III trial of the drug in May 2019 after initial data suggested it would not benefit people in the early stages of Alzheimer’s disease (stopping the study was not based on safety concerns). However, new findings from a follow-up on study participants, who had received greater exposure to a higher dose of the drug, showed significant slowing in clinical decline in early Alzheimer’s disease, preserving greater memory and everyday living skills.
Biogen is planning a new study to re-offer the drug to eligible participants from earlier trials. Some of the trial participants were recruited through Join Dementia Research (JDR). This highlights the importance of Alzheimer Scotland’s partnership with JDR, in giving people the opportunity to take part in research studies.
The drug will need to be approved by regulators before it could be offered more widely. The regulatory process won’t begin in the USA until next year, which would need to be followed by a European process and a process of deciding whether to make it available on NHS.
Henry Simmons, Chief Executive said:
“Alzheimer Scotland warmly welcomes this very positive news about Aducanumab from Biogen. The results gathered from the additional data are indeed promising and we look forward to monitoring the outcomes of the next steps in the trial process. Whilst encouraging it is important to note that there is still some way to go before this, or any drug of this nature, becomes readily available and the reality is that we must continue to secure greater investment in further research in order to secure further disease modifying drugs and interventions.
“An important part of this process will be ensuring that there are enough people both living with the disease and those without a diagnosis signed up to participate in research and we would encourage anyone interested in this to Join Dementia Research (JDR) and help us ensure Scotland has the best possible research infrastructure to secure investment in trails of this nature. You can do this by signing up to JDR.