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? 

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

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Clinical Trials

More from R&D