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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Biogen has warned that uptake for its newly approved Alzheimer’s therapy will be slow in the beginning and doctors confirm it will take time to figure which patients can and should be treated.
Experts say there should be enough Alzheimer’s patients willing to enroll in Biogen/Eisai’s US FDA-required Phase IV trial and other companies’ late-stage studies even with Aduhelm broadly available.
Given mixed Phase III results for the Alzheimer’s drug and potentially severe side effects for the once-monthly infused therapy, ICER’s recommendation came in below analyst expectations.