Biogen’s Big Day Arrives, But Aducanumab Results Don’t Answer Key Question
Biogen presented highly anticipated data in Alzheimer’s disease at CTAD for its Phase III EMERGE and ENGAGE studies, but one major question remains unanswered: will the FDA approve the drug?
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Alzheimer’s patients treated with the amyloid protofibril-clearing antibody had slower disease progression compared to placebo, with differences increasing over time. Safety concerns, however, are growing.
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.
In addition to its uncertain attempt at near-term revenue growth with Eisai-partnered lecanemab, Biogen recently ended multiple R&D programs and will pay $900m to settle a whistleblower lawsuit.