“The whole concept of senior living will change,” CNBC’s Jim Cramer said Tuesday, discussing the news that Biogen and Eisai plan to seek regulatory approval of their investigational treatment for early Alzheimer’s disease, aducanumab.
The companies announced Tuesday that they made the decision after consulting with the Food and Drug Administration. Studies of the drug had been discontinued in March, but Biogen said that a new analysis involving a larger dataset of Phase 3 studies showed success with a higher dose of the drug.
“Patients who received aducanumab experienced significant benefits on measures of cognition and function such as memory, orientation and language,” Biogen said in a news release. “Patients also experienced benefits on activities of daily living, including conducting personal finances, performing household chores such as cleaning, shopping and doing laundry, and independently traveling out of the home.”
Biogen said it plans to submit a biologics license application in the United States early next year and will continue talks with regulatory authorities in international markets including Europe and Japan.
“We are hopeful about the prospect of offering patients the first therapy to reduce the clinical decline of Alzheimer’s disease and the potential implication of these results for similar approaches targeting amyloid beta,” Biogen CEO Michel Vounatsos said in the news release.
Aducanumab also would become the first therapy to demonstrate that removing amyloid beta results in better clinical outcomes.
The Alzheimer’s Association said it was “encouraged” by the news that Biogen was seeking regulatory approval.
“We eagerly anticipate reviewing a full report of the findings from these studies and participating in a robust discussion of data,” the association said in a statement.