A potential Alzheimer’s treatment has been granted ‘priority review’ status by America’s medicines regulator, speeding up the approval decision-making process. US-quoted Biogen (US:BIIB) and Tokyo-listed Eisai (TYO:4523) revealed last Friday that the Food and Drug Administration (FDA) had accepted an application for their investigational therapy ‘aducanumab’, with a decision expected by 7 March next year. According to the companies, which have worked together on the development and commercialisation of aducanumab since 2017, the FDA has said that “if possible, it plans to act early on this application”.
The FDA intends to hold an advisory committee meeting for the application, on a date that has not yet been fixed. Biogen did not use a priority review voucher for the filing. Shares in the group closed up by about 10 per cent on Friday.
Alzheimer’s is a progressive disease that can affect memory, thinking and other brain functions, and which can cause premature death. According to the NHS, it is the most common type of dementia in the UK. As things stand, there is no cure for the condition, but there are therapies available which can help to alleviate some of its symptoms. Biogen and Eisai say that the potential approval of aducanumab would see it become the first treatment to reduce the clinical decline of Alzheimer’s.
The announcement from Biogen and Eisai didn’t come out of the blue. Last October, it was revealed that Biogen was planning a regulatory filing for aducanumab. But that announcement followed on from the discontinuation of trials for the same drug in March 2019. Biogen explained in the autumn that its fresh decision to file was based on positive results from a new analysis, conducted in consultation with the FDA, of a larger dataset from phase three (late-stage) clinical trials. It said that the previous trials “relied on an earlier and smaller dataset”.
