1. Scrip
  2. >>Therapy Areas
  3. >>Neurological

Biogen Expects Confirmatory Aduhelm Data In 2026, But Is It Too Late?

Data on rivals will be available well before

 
• By Jessica Merrill

Biogen's update on the timeline for running a confirmatory study of the Alzheimer's treatment is faster than the nine years required by FDA under the accelerated approval.

Biogen
Biogen plans to begin an Aduhelm confirmatory study in May • Source: Alamy

Biogen, Inc.'s Phase IV post-marketing confirmatory trial of Aduhelm for the treatment of Alzheimer's disease is on track to begin enrolling patients in May 2022 – with the expectation that data will be available in 2026. By then, the safety and efficacy profile of beta amyloid clearing antibodies will already be clearer, informed by rival drugs.

Biogen updated investors and the public on 16 December on the timeline for the confirmatory trial, required by the US...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip 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
Start Free Trial

Already a subscriber?

More from Neurological

Supernus Secures Sage With CVR-Supported Deal

 
• By Jessica Merrill

Supernus agreed to pay $561m upfront plus a contingent value right that could add $234m to buy Sage, topping a previously rejected offer from Biogen.

Who Dares Wins? Roche Moves Parkinson’s Candidate Into Phase III Despite Near Miss

 
• By Andrew McConaghie

Open-label extension data have persuaded Roche to move prasinezumab into Phase III, where it believes a few tweaks to the study design could turn a near miss into success.

Vigil’s Iluzanebart Disappoints In Rare Neurodegenerative Disease

 
• By Jessica Merrill

The Phase II TREM2 agonist is not part of Sanofi’s planned acquisition.

Atai/Beckley Merger Comes At A Transformative Time For Psychedelics

 
• By Kevin Grogan

All eyes are on the upcoming readout of BPL-003 for treatment-resistant depression.

More from Therapy Areas

Who Dares Wins? Roche Moves Parkinson’s Candidate Into Phase III Despite Near Miss

 
• By Andrew McConaghie

Open-label extension data have persuaded Roche to move prasinezumab into Phase III, where it believes a few tweaks to the study design could turn a near miss into success.

Quick Listen: Scrip’s Five Must-Know Things

 
• By Ian Haydock

In this week's episode: breaking down big pharma’s executive pay; US vaccine panel upheaval; Merck’s RSV approval; MFN and Japan; and the future of Pfizer and Arvinas’s partnership.

UroGen Gets A First-Ever Bladder Cancer Approval Despite US FDA AdComm ‘No’ Vote

 
• By Joseph Haas

UroGen’s Zusduri was approved despite an advisory committee vote recommending against it in May. It is the first approved drug for a type of recurring bladder cancer.