» One of the world’s first blood test kits to detect signs of Alzheimer’s disease has been approved in Japan. The approval could lead to quicker and easier diagnoses of the disease, advocates claimed. The amyloid beta measuring product was developed by Sysmex Corp.
» The Food and Drug Administration did not follow its own protocol in a 2021 decision to approve the Alzheimer’s drug aducanumab (Aduhelm), a US House investigation determined. The news preceded an expected decision on lecanemab, an Alzheimer’s drug in the same anti-amyloid class and involving the same maker.
The report, released Dec. 29, called drugmaker Biogen’s launch plans of aducanumab “aggressive,” its pricing too high and the FDA’s decision to approve it unorthodox. Investigators also criticized the FDA’s broad label indication for aducanumab and Biogen’s acceptance of that label, “despite a lack of clinical data on all Alzheimer’s disease stages and Biogen’s reservations.”
“This report documents the atypical FDA review process and corporate greed that preceded FDA’s controversial decision to grant accelerated approval to Aduhelm,” said Frank Pallone Jr. (D-NJ), chairman of the Energy and Commerce Committee.
» US Senators are asking federal officials to revisit a nine-year-old Medicare determination that severely limits coverage of diagnostic brain scans for dementia. Currently, Medicare will cover one amyloid positron emission tomography scan per lifetime while the patient is enrolled in certain clinical studies. With new evidence supporting the efficacy of those scans for dementia diagnoses, Sens. Kevin Cramer (R-ND) and Edward Markey (D-MA) called for coverage that would support expanded patient access and encourage clinicians to use this technology.
» Blacks and Hispanics in the United States have an outsized risk of Alzheimer’s disease, in part due to vascular risk linked to socioeconomic disadvantage, a new study has found.
Lower incomes and lack of access to health insurance and medical care can lead to vascular-related diseases such as diabetes, hypertension and obesity in midlife and late life. This, in turn, significantly raises the odds of developing Alzheimer’s, according to researchers from the University of Miami Miller School of Medicine.
