A scientist works in a laboratory at Biogen in Cambridge, MA on November 5, 2016.
Suzanne Kreiter | Boston Globe | Getty Images
Biogen and Japan's Eisai said Friday the U.S. Food and Drug Administration had issued an expedited review for the marketing of their potential blockbuster Alzheimer's drug, aducanumab.
Biogen shares rose 10% to $ 306 before the bell.
If approved, aducanumab would be the first treatment to delay the progression of the deadly, mind-numbing disease, of which the U.S. Centers for Disease Control and Prevention reports is expected to have 13.9 million Americans, or 3.3%, by 2060. the population of the country will be affected.
It's been several years since the FDA considered a new Alzheimer's treatment application because tested drugs failed. The agency is expected to make a decision by March 7, but intends to act early if possible, the companies said.
Biogen revived plans to seek approval for the treatment in October, months after the drug's development was phased out following disappointing study results.
Wall Street analysts disagreed on the data from the clinical trials.
"There are still a lot of questions about the aducanumab dataset," said Stifel analyst Paul Matteis.
The drug agency would consult a panel of external experts to approve the drug at a time yet to be determined, the companies said. The agency is not required to follow the panel's recommendation, but it often does.
"We largely view an advisory board as one of the big 'clearing events' and predict that it will be 'mixed' which will keep the road in the balance," said Jefferies analyst Michael Yee.
The FDA has granted a priority review that allows it to expedite the review of a drug application for the treatment of an unmet medical need.
Biogen said it did not use its priority check voucher on aducanumab use.