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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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.
TRAILBLAZER-ALZ met the primary, but not most secondary endpoints. Lilly said efficacy of its amyloid-clearing agent depends on tau levels at baseline and reductions in some parts of the brain.
Lilly reported positive results from a Phase II pivotal trial of donanemab, which targets a modified form of beta-amyloid called N3pG, and has a second pivotal Phase II study under way.