FDA approves treatment for people with mild forms of Alzheimer’s

Jaimy Lee

The Food and Drug Administration on Friday granted accelerated approval to Eisai and Biogen’s new Alzheimer’s disease treatment

The Food and Drug Administration on Friday granted an accelerated approval to Eisai and Biogen’s Alzheimer’s disease treatment, which showed in clinical trials that it can slow the progression of the disease.

U.S.-listed shares of Eisai (4523.TO) rallied 9.4% after the news was announced on Friday afternoon. Biogen’s (BIIB) stock was halted at the time of publication.

The drug, lecanemab, is now called Leqembi and will cost $26,500 a year, according to an Eisai spokesperson. It’s approved for patients with mild cognitive impairment or mild dementia, the FDA said.

“The approval of Leqembi provides new hope to patients with Alzheimer’s disease,” Biogen CEO Christopher Viehbacher said in an emailed statement. “Patients at an early stage of the disease and their caregivers can now consider a new treatment option with their doctors.”

It’s the second drug in a category of amyloid plaque-clearing medicines to receive FDA approval. Biogen and Eisai also brought to market that therapy, but the drug, Aduhelm, failed to gain traction in the clinic after its controversial accelerated approval in 2021.

An accelerated approval is a type of quick approval used to commercialize treatments when there is an unmet need. Eisai has said plans to seek full approval of Leqembi early this year.

Eisai’s stock has gained 18.6% over the past year, while Biogen’s shares are up 18.5%. The S&P 500 has declined 19.0% over the past 12 months.

-Jaimy Lee

(END) Dow Jones Newswires

01-07-23 0907ET