Aduhelm’s Revised Labeling Could Help Payers Navigate Reimbursement
The US FDA revised labeling to clarify the target population, which could be helpful in reimbursement discussions for the Alzheimer's therapy.
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Eisai/Biogen’s Leqembi Will Launch Below Aduhelm At $26,500 Per Year
With accelerated approval granted and a supplemental filing for full approval in the FDA's hands, Eisai set a price it says is below the “societal value” its Alzheimer’s drug provides as it prepares to seek Medicare coverage. Labeling notably comes with no black box warning or safety restrictions despite various concerns.
CTAD 2022 Preview: Lecanemab Is Headliner After Gantenerumab’s Failure
Phase III results for Eisai/Biogen’s lecanemab are the main event at the Clinical Trials on Alzheimer’s Disease meeting, but other data – even Roche’s failed Phase III gantenerumab studies – also may have implications for the amyloid-clearing antibody.
How Biogen’s Aduhelm Bet Became A Commercial Bust
Biogen caught a lucky break in getting the first FDA approval for a potentially disease-modifying Alzheimer’s therapy, but doubt over clinical benefit and commercial missteps have left Biogen in a precarious position a year later.