Morning Briefing
Summaries of health policy coverage from major news organizations
Using Aduhelm Trick, Biogen Seeks Approval For Another 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鈥檚 disease 鈥 based on the same relaxed standard used last June to win a highly contested approval for Aduhelm. The two companies said a 鈥渞olling submission鈥 to the Food and Drug Administration for the Alzheimer鈥檚 drug called lecanemab has been initiated and will likely be completed in the next several months. (Feuerstein, 9/28)
Mass General Brigham, the state鈥檚 largest health care provider, said Tuesday that it will not administer Biogen鈥檚 controversial new Alzheimer鈥檚 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鈥檚 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鈥檚 decision holds special significance because of its proximity to Biogen. (Saltzman, 9/28)
KHN: Alzheimer鈥檚 Drug Targets People With Mild Cognitive Impairment. What Does That Mean?
The approval of a controversial new drug for Alzheimer鈥檚 disease, Aduhelm, is shining a spotlight on mild cognitive impairment 鈥 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鈥檚, the groups in which the medication was studied. (Graham, 9/29)
And research suggests a link between depression and dementia 鈥
Depression in young adulthood might increase risk for cognitive impairment in old age, a new UCSF study has found. The study 鈥 which used predictive models to determine depressive symptoms over a lifetime 鈥 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)