An experimental Alzheimer’s drug will get an accelerated review for approval from the US Food and Drug Administration, the treatment’s makers announced Friday.
Aducanumab, a drug made by Biogen and Japan’s Eisai the companies is the first application in 17 years to be reviewed by the agency for a treatment of the mind-robbing disease.
Biogen’s shares rose by nine percent to $302.75, before falling back to $301.50.
If approved, aducanumab would be the first treatment designed to delay progression of Alzheimer’s disease, which is expected to affect 13.9 million Americans or 3.3 percent of the country’s population, by 2060, according to the US Centers for Disease Control and Prevention (CDC).
The highly-anticipated drug improved brain function for patients who got enough of the medication, Biogen said following a review data from its large, late-stage studies last year.
The FDA agreed to a priority review with a decision expected by March 7, the companies said, faster than the 10 months typically expected under a standard review.
The companies added in a statement that the agency ‘has stated that, if possible, it plans to act early on this application.’
‘For the FDA to come and state that they will try and review it earlier is a pretty big deal,’ Guggenheim analyst Yatin Suneja said.
Biogen said regulators had agreed to speed up the review without the company using a voucher that ensures a fast consideration, which some analysts said could be viewed as a sign of FDA interest.
‘This can be interpreted as suggesting that the agency is comfortable with the data and is seriously considering approval based on the first cycle,’ said Cowen analyst Phil Nadeau.
Aducanumab is an antibody drug designed to seek and destroy amyloid beta, protein plaques that form in the brain and are a hallmark of Alzheimer’s disease.
Scientist believe that these plaques are at least partially responsible for memory loss and cognitive decline in Alzheimer’s patients.
But the drug has had a tumultuous journey.
Biogen in October revived plans to seek approval for the treatment, months after scrapping the development of the drug following disappointing study results.
The firm halted two large, late-stage studies last year, citing no apparent benefit.
Disappointment rippled through the Alzheimer’s and scientific communities. Some even questioned whether amyloid beta was the right target for treatments at all.
Five months later, after looking at the data with fresh eyes Biogen announced it did in fact help patients, so long as the dosage and timing were high and early enough.
Wall Street analysts, however, remain divided about the data from the clinical studies.
‘There still are a ton of questions surrounding the aducanumab dataset,’ Stifel analyst Paul Matteis said.
The FDA is planning to hold a meeting of outside experts on the application on a yet-to-be-determined date, the companies said.
The agency is not required to follow the recommendation of such advisory committees, but often does.
‘We largely view an advisory committee as one of the big ‘clearing events’ and predict it will be ‘mixed,’ leaving the Street in limbo,’ Jefferies analyst Michael Yee said.