The US Court of Appeals for the First Circuit yesterday reversed a lower court’s ruling on one specific claim linked to investor allegations that Biogen made misleading statements about its Alzheimer’s drug Aduhelm (aducanumab), its dose-response relationship and the correlation (or lack thereof) between amyloid plaque removal and clinical improvement.
The investors claimed Biogen concealed subgroup-level clinical data that contradicted earlier statements around Aduhelm’s efficacy. Aduhelm, which won an accelerated approval in 2021, has failed to take off in sales because of a lack of insurance coverage due to lingering questions about how well it works. It remains unknown what Biogen plans to do now with the drug since Biogen’s other, newer, amyloid-targeted, Eisai-partnered drug, Leqembi (lecanemab), is readying for wider uptake.
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