Accelerated Approval Of Lilly’s Alzheimer’s Drug Could Last About 15 Months, CEO Says
Lilly expects results from donanemab ongoing confirmatory trial in 2023, while Biogen has nine years to finish its postmarket study. CEO David Ricks discusses impact of aducanumab approval backlash, pricing and national coverage decision at STAT summit.
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Lilly plans a head-to-head study of donanemab versus Biogen’s Aduhelm to see which clears amyloid plaque better and has begun a rolling BLA toward accelerated approval of the Alzheimer’s drug.
Medicare Coverage For Alzheimer’s Treatments Should Have Flexibilities For Labeling Differences, Developers say
Lilly and Genentech express concern that the Centers for Medicare and Medicaid Services will set Medicare coverage parameters for their Alzheimer’s drugs even before all the data is in.
Former CMS chief Mark McClellan discusses what kind of study requirements Medicare might impose if it decides to only cover the new Alzheimer’s drug if in the context of further evidence generation.