Late-Stage Trials Of Alzheimer’s Drug Show Promising Results
Eisai says that its experimental treatment, developed with Biogen, slowed the rate of cognitive decline by 27% in trial participants who are in the early stages of Alzheimer's. Earlier trial data was already submitted to the FDA for accelerated approval review.
Stat:
Alzheimer’s Treatment Slowed Cognitive Decline In Closely Watched Trial
An investigational Alzheimer’s disease treatment from Biogen and Eisai slowed the rate of cognitive decline by 27% in a clinical trial, the companies said Tuesday, meeting the goals of a closely tracked study and strengthening the drug’s case for approval as early as January. (Garde and Feuerstein, 9/27)
USA Today:
Alzheimer's Drug Slowed Decline In Late-Stage Study: Eisai And Biogen
In a widely-anticipated study, Eisai and Biogen on Tuesday said their Alzheimer's drug slowed cognitive decline among people with early signs of the disease. The study, led by Eisai, which has teamed with Biogen to develop the drug called lecanemab, showed the drug targeting amyloid beta in the brains of study participants slowed memory and thinking problems. (Alltucker, 9/27)
The Washington Post:
Experimental Alzheimer’s Drug Slows Cognitive Decline In Trial, Firms Say
The upbeat news served as a stark contrast to the calamitous rollout last year of another drug, marketed as Aduhelm, sponsored by the two companies. Like Aduhelm, lecanemab reduces abnormal clumps of beta amyloid, a hallmark of Alzheimer’s. But unlike Aduhelm, for which the data was confused and conflicting, the trial results for lecanemab told a straightforward and encouraging story, some experts said. Aduhelm was approved by the Food and Drug Administration, but Medicare refused to cover it broadly, and the drug collapsed in the marketplace. (McGinley, 9/27)
The New York Times:
Alzheimer’s Drug Slows Cognitive Decline In Key Study
Eisai had already applied for accelerated approval, the type of approval given to Aduhelm. The process allows the Food and Drug Administration to greenlight drugs if they have uncertain evidence of benefit but affect a disease’s biological pathway in a way that is considered reasonably likely to benefit patients. The company said on Tuesday night that it would first continue with the accelerated approval process, with an F.D.A. decision expected by early January, and then use the newer data to seek full approval. (Accelerated approval requires companies to do further trials and prove that their drug works.)Analysts predict that lecanemab, or any effective Alzheimer’s medication, would most likely be a multibillion-dollar blockbuster. (Robbins and Belluck, 9/27)
Reuters:
Eisai, Biogen Say Alzheimer's Drug Succeeds In Slowing Cognitive Decline
Eisai said results from the 1,800-patient trial prove the longstanding theory that removal of sticky deposits of a protein called amyloid beta from the brains of people with early Alzheimer's can delay advance of the debilitating disease. (Beasley and Steenhuysen, 9/27)
In related news about Alzheimer's disease —
Stat:
In Texas, A Bold Plan To Diversify Alzheimer’s Research Takes Shape
Gladys Maestre is on a scouting mission. The Alzheimer’s disease researcher is driving through Southmost, a Mexican American neighborhood just north of looming sections of the border wall and a checkpoint that leads to Mexico. (McFarling, 9/28)
Stat:
Where Caregiving Is A Family Affair, Alzheimer's Is A Heavy Burden
Here in the Rio Grande Valley almost everyone knows, or cares for, someone with dementia. The region has some of the nation’s highest rates of the disease. (McFarling, 9/28)
