Alzheimer’s disease
CMS says it would only cover the cost of Biogen’s Aduhelm and any required scans “if they are enrolled in qualifying clinical trials.”
The planned testing for DNL919 was held back pending additional documentation required to initiate the studies and information on the preclinical toxicology assessment.
CMS issued a draft decision for Biogen’s Alzheimer’s drug and said it would only cover the cost of Aduhelm and any required scans “if they are enrolled in qualifying clinical trials.”
Arkuda seeks to disrupt the usual progression of neurodegenerative disease with medicines developed by applying cutting-edge knowledge from the domains of lysosomal and microglial biology.
ALZ-801 is administered orally and works by blocking the formation of neurotoxic soluble amyloid oligomers that later lead to cognitive decline in Alzheimer’s patients.
The company indicated that its timeline for an accelerated approval request for its own Alzheimer’s drug, donanemab, was no longer on schedule for the first quarter after the CMS draft guidance.
Up to 40% of AD patients were found to have Lewy Bodies in their brain after succumbing to the disease.
Scientists believe that, perhaps, Alzheimer’s disease is a cause of not just beta-amyloid accumulation but, digging more deeply, immune system dysfunction.
Clinical trial news definitely picked up this final week of January. Here’s a look.
Alzamend Neuro is looking to commence a Phase II multiple ascending dose study of lead compound, AL001, in Alzheimer’s disease during the second quarter of this year.
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