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Latest From Biogen, Inc.
AC Immune has seen two big disappointments in its Alzheimer’s pipeline this year, but its partner Johnson & Johnson has put its faith in a novel vaccine-like approach to targeting the disease.
Lilly’s donanemab showed faster, deeper amyloid clearance versus Biogen/Eisai’s Aduhelm and Roche’s failed Phase III gantenerumab studies showed the importance of deep, rapid removal.
Beginning confirmatory trials before the accelerated approval is granted shortens the time between clearance and the confirmation of benefit, when patients are at risk, said Oncology Center of Excellence Director Richard Pazdur.
Centers for Medicare and Medicaid Services’ standard for determining whether drugs produce a clinically meaningful improvement in cognition that would allow for broader Medicare coverage is unclear. But Eisai/Biogen’s lecanemab is likely to serve as a first test.
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