Using Aduhelm Trick, Biogen Seeks Approval For Another Alzheimer’s Drug
The new drug from Biogen and partner Eisai, lecanemab, will attempt to use the same process that led to the recent approval of controversial drug Aduhelm. Meanwhile, Massachusetts' biggest health care provider, Mass General Brigham, has said it will not offer Aduhelm to patients.
Biogen, Eisai Seek Fast Approval For Second Alzheimer's Drug
Biogen and its Japanese partner Eisai announced Monday evening the start of an application process that will seek a fast U.S. approval for an experimental treatment for Alzheimer’s disease — based on the same relaxed standard used last June to win a highly contested approval for Aduhelm. The two companies said a “rolling submission” to the Food and Drug Administration for the Alzheimer’s drug called lecanemab has been initiated and will likely be completed in the next several months. (Feuerstein, 9/28)
The Boston Globe:
Mass General Brigham Won’t Offer Biogen’s New Alzheimer’s Drug
Mass General Brigham, the state’s largest health care provider, said Tuesday that it will not administer Biogen’s controversial new Alzheimer’s drug to patients, dealing another setback to the Cambridge company and its expensive treatment. The network, which includes the flagships Massachusetts General Hospital and Brigham and Women’s Hospital, is the latest major US health care system to opt against offering monthly infusions of the drug, called Aduhelm, over concerns about its safety and effectiveness. The Cleveland Clinic, Mount Sinai Health System in New York, and Providence in Renton, Wash., made similar moves in July after weighing the risks and benefits of the medicine. But Mass General Brigham’s decision holds special significance because of its proximity to Biogen. (Saltzman, 9/28)
Alzheimer’s Drug Targets People With Mild Cognitive Impairment. What Does That Mean?
The approval of a controversial new drug for Alzheimer’s disease, Aduhelm, is shining a spotlight on mild cognitive impairment — problems with memory, attention, language or other cognitive tasks that exceed changes expected with normal aging. After initially indicating that Aduhelm could be prescribed to anyone with dementia, the Food and Drug Administration now specifies that the prescription drug be given to individuals with mild cognitive impairment or early-stage Alzheimer’s, the groups in which the medication was studied. (Graham, 9/29)
And research suggests a link between depression and dementia —
San Francisco Chronicle:
Risk Of Dementia 73% Higher For People With These Symptoms In Early Adulthood, UCSF Study Says
Depression in young adulthood might increase risk for cognitive impairment in old age, a new UCSF study has found. The study — which used predictive models to determine depressive symptoms over a lifetime — found that the chances of cognitive impairment were 73% higher for those estimated to have elevated depressive symptoms in early adulthood, and 43% higher for those estimated to have elevated depressive symptoms in mid- and later life. (Echevarria, 9/28)