REPORT: Biogen, Eisai Began Application For Alzheimer’s Drug

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Biogen, and its Japanese partner Eisai, announced Monday that it plans to begin the process for U.S. approval for its experimental drug for Alzheimer’s.

Biogen and Eisai announced “rolling submission” to the Food and Drug Administration (FDA) for its second Alzheimer’s drug, lecanemab, according to a company press release. The companies expect the submission to be completed in the next several months.

Lecanemab reduces the level of toxic plaques in the brain that is associated with early Alzheimer’s disease, according to the company press release.

The submission of approval is based on a proof of concept study involving 856 patients with mild cognitive impairment due to Alzheimer’s disease, according to the press release. After 18 months of treatment using lecanemab, over 80% of the participants saw a reduction in the plaques and slowed cognitive decline. After the first 12 months of the trial, the study did not see the results the company anticipated.

“With the worldwide population growing and aging, the number of people living with A.D. (Alzheimer’s disease) is on the rise. A.D. imposes an enormous burden on not only people living with A.D. and their families but also for society,” Haruo Naito, chief executive officer at Eisai, said in the press release.

“The lecanemab rolling BLA submission marks a new milestone toward the advancement of a treatment system for A.D.,”

Biogen used the same “rolling submission” process to win approval for its Alzheimer’s disease drug, Aduhelm, in June, according to Reuters. The approval was controversial due to mixed results from the company’s trial studies.

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“We believe that treatments directed at amyloid-beta reductions in the brain have the potential to transform diagnosis and treatment of Alzheimer’s disease,” Michel Vounatsos, chief executive officer at Biogen, said in the press release.

“We look forward to continuing to work with Eisai to pioneer science, advance knowledge, and serve the needs of Alzheimer’s patients,” Vounatsos said.

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