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

Ionis Targets Ultra-Rare Disease Market With Zilganersen

 
• By Alaric DeArment

The biotech announced positive topline results from its pivotal study in Alexander disease, which has an estimated population of about 300 in the US.

Sanofi’s Pipeline Pressure Continues As Tolebrutinib Trips Near Finish Line

 
• By Manas Mishra

Sanofi’s MS hopeful tolebrutinib hits a regulatory hurdle in the US, renewing pressure on the firm’s pipeline. Analysts hope the delay won’t prove material.

Capsida Is Latest To Have Patient Fatality In Gene Therapy Trial

 
• By Alaric DeArment

The privately owned biotech said it would pause its Phase I/II study of CAP-002 in STXBP1-related disorders after the first patient in the study died.

Lundbeck CEO Looks To The Future With Sharper Commercial Focus

 
• By Kevin Grogan

Charl van Zyl tells Scrip that pipeline is the priority as the company discontinues commercial operations in 27 markets.

More from Therapy Areas

Roche’s evERA Giredestrant Study Hits In All-Comer Breast Cancer Population

 
• By Alexandra Shimmings

The Phase III trial of the SERD has shown a significant benefit in the intent-to-treat and ESR1-mutated populations in post-CDK ER+/HER2- metastatic breast cancer but whether the data will be enough to support an equally broad approval remains to be seen.

Sanofi’s Pipeline Pressure Continues As Tolebrutinib Trips Near Finish Line

 
• By Manas Mishra

Sanofi’s MS hopeful tolebrutinib hits a regulatory hurdle in the US, renewing pressure on the firm’s pipeline. Analysts hope the delay won’t prove material.

Why India Revoked The Entresto Patent And Novartis Abstained From Proceedings

 
• By Anju Ghangurde

India revokes Novartis's patent pertaining to Entresto, upholding the objections of opponents including the Indian Pharmaceutical Alliance on lack of novelty and prior claiming, among others. Novartis decided against participating in the hearings.