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Biogen’s Big Day Arrives, But Aducanumab Results Don’t Answer Key Question

 
• By Mandy Jackson

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? 

question mark on a woman's hand. - Image
Unanswered: Is FDA approval of aducanumab possible? • Source: Shutterstock

Biogen’s closely watched Phase III results for its amyloid-targeting therapy aducanumab in the treatment of patients with early Alzheimer’s disease, presented on 5 December at the Clinical Trials in Alzheimer’s Disease (CTAD) meeting in San Diego, did not answer a big outstanding question: Can the drug win US Food and Drug Administration approval?

The company presented a complex dataset, including results only for patients treated with the highest dose of aducanumab based on a fourth and final clinical trial protocol change that allowed for patients with the ApoE4 gene to be titrated up to the highest dose

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