Alzheimer's drug from Biogen to get speedy U.S. review

[August 08, 2020]  By Dania Nadeem and Manojna Maddipatla

(Reuters) - The U.S. Food and Drug Administration will conduct an expedited review of an experimental Alzheimer's drug from Biogen Inc and Japan's Eisai Co Ltd, the companies said on Friday, the first application in 17 years to be reviewed by the agency for a treatment of the mind-robbing disease.

Biogen's shares were up 9% at $302.75.

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% of the country's population, by 2060, according to the U.S. Centers for Disease Control and Prevention.

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

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.

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.

(This story is refiled to delete extraneous words in second paragraph)

(Reporting by Manojna Maddipatla and Dania Nadeem in Bengaluru; Editing by Shounak Dasgupta, Lewis Krauskopf and Tom Brown)

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