Biogen-Eisai Alzheimer's Drug Gets FDA Priority Review

Biogen and Eisai said the FDA accepted for priority review their marketing application for aducanumab, an Alzheimer’s treatment.
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Biotechnology titan Biogen  (BIIB) - Get Report and Japanese pharmaceutical heavyweight Eisai  (ESALY)  said Friday that the U.S. Food and Drug Administration accepted for priority review their marketing application for aducanumab, an Alzheimer’s treatment.

“If approved, aducanumab would become the first therapy to reduce the clinical decline of Alzheimer’s disease and would also be the first therapy to demonstrate that removing amyloid beta resulted in better clinical outcomes,” the companies said in a statement.

Biogen shares recently traded at $300.93, up 8.4%. The stock slid 6% this year through Thursday, compared with a 3% increase for the S&P 500 and a 24% climb for the Nasdaq Composite.

The FDA will consult a panel of outside experts about clearance for aducanumab. The agency isn’t bound to act according the panel’s suggestion, but it frequently does, Reuters reports.

If approved, aducanumab might be a multibillion-dollar seller, analysts told Reuters. The FDA hasn’t reviewed an application for a new Alzheimer’s treatment since 2003.

"We believe aducanumab's potential to become the first product to be approved that could alter the course of Alzheimer's disease means investors can no longer afford to sit on the sidelines" for Biogen stock, Canaccord  Genuity analyst Sumant Kulkarni wrote in a report.

"We continue to believe Biogen affords significant potential for upside, as the fear of missing out, a key tenet of our buy thesis, becomes even more real for investors now."

Kulkarni rates Biogen stock buy with a $350 price target.

“I am heartened by what this progress may mean for people living with Alzheimer’s disease,” Christopher van Dyck, a physician who directs the Yale Alzheimer’s Disease Research Center, said in the companies’ statement.

“If aducanumab is determined to be effective in reducing the decline in cognition and activities of daily living resulting from progression of this disease by addressing the underlying disease pathology, it will deliver meaningful benefits to those who most need them.”

Alzheimer’s is the most prevalent form of dementia, with 5.7 million Americans who are over 65 suffering from it.