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 Food and Drug Administration as part of the accelerated approval of Aduhlem in June

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

Lilly And Alchemab Tap Into Resilient Individuals To Develop ALS Drug

 
• By Andrew McConaghie

The pharma company is helping to validate the biotech’s model by developing a novel amyotrophic lateral sclerosis candidate, based on its novel approach that ‘turns drug discovery on its head’.

Accelerated Approval May Be Out Of Reach For PTC’s Huntington’s Drug

 
• By Joseph Haas

PTC said its updated Phase II data for PTC 518 met the primary endpoint of Huntingtin’s protein reduction, but analysts said there isn’t clear correlation with clinical benefit.

In Brief: Ferrer Signs Deal For Prilenia’s Pridopidine In Europe

 
• By Sushmita Panda

The companies will co-develop the drug for additional indications beyond Huntington’s disease, while Prilenia retains rights in key global markets.

CNS, Cardiometabolics A Bright Spot In Recent Chinese VC/PE Fundings

 
• By Dexter Jie Yan

Over the past few months, Chinese developers of CNS and cardiometabolic therapies have attracted the interest of domestic investors, amid generally modest funding activity.

More from Therapy Areas

Merck & Co. CMO Barr On Breaking Into Immunology And Ophthalmology

 
• By Jessica Merrill

Chief medical officer Eliav Barr discussed Merck’s investment in new therapeutic areas and business development in an interview with Scrip.

AstraZeneca COPD Drug Breztri Breezes Through Asthma Trials

 
• By Kevin Grogan

The triple therapy improves lung function in the Phase III KALOS and LOGOS studies

Zepbound Grows, But CVS/Novo Nordisk Deal For Wegovy Casts Shadow

 
• By Alaric DeArment

Lilly executives told the company’s Q1 call they were not surprised at the Wegovy deal, but some analysts said it could cut into prescription growth for Zepbound.