It aims at reducing the clinical decline of the disease, which accounts for 60-80% of dementia cases, rather than the underlying cause.
It would stop the deterioration of cognitive abilities so patients can perform daily activities, including conducting personal finances, performing household chores and independently travelling out of the home.
The FDA, which granted priority review to aducanumab, is expected to take a decision by next March.
The pharma company stopped the final phase of clinical trials last year after early data showed it would not be beneficial for patients in the early stages of the disease.
But Biogen applied to the FDA after retrieving a wider pool of data, while it is also planning a new study involving the same participants of the previous trial.
“We believe that aducanumab marks the beginning of a new era of potential treatments for Alzheimer’s disease that will inspire even more discovery and innovation to bring hope to those affected by this devastating disease,” said chief executive Michel Vounatsos.
Shares added 1% to US$309.34 in premarket trading.