Free Access To High-Cost Aducanumab May Incentivize Phase IV Trial Participants

Accelerated Approval Adds Another Alzheimer’s Study To Global Pipeline

Experts say there should be enough Alzheimer’s patients willing to enroll in Biogen/Eisai’s US FDA-required Phase IV trial and other companies’ late-stage studies even with Aduhelm broadly available. 

Senior patient listens to his doctor
The confirmatory trial for Aduhelm also is likely to enroll a significant number of ex-US patients • Source: Alamy

The requirement for Biogen, Inc. and Eisai Co., Ltd. to conduct a Phase IV clinical trial as a condition of Aduhelm’s accelerated approval raises the question of whether Alzheimer’s disease patients in the US will be willing to enroll in the trial – or in other companies’ large, late-stage studies – when the drug is broadly available following its 7 June US Food and Drug Administration approval.

More from Clinical Trials

Edgewise’s HCM Candidate May Provide Advantages Over BMS’s Camzyos

 
• By 

With new Phase II data, Edgewise asserted that EDG-7500, a sarcomere modulator, could offer better efficacy and safety than cardiac myosin inhibitors in hypertrophic cardiomyopathy.

AbbVie On A STEAP Learning Curve In ADCs

 

Investing heavily in antibody-drug conjugates, AbbVie is pioneering a dual STEAP1xPSMA-targeting approach in prostate cancer, as other candidates advance.

Boehringer Still Sees Plenty Of Juice In Jardiance

 
• By 

Strong sales growth for the German group’s SGLT2 inhibitor in 2024

Hengrui Renews Global Phase III Push As China Players Plan Pivotal Multinational Trials

 

After a more than three-year hiatus, China's Hengrui has signalled its return to multiregional Phase III trials as it looks to globalize its innovative pipeline. Meanwhile, a number of other Chinese players have announced plans to kick off Phase III trials this year and beyond.

More from R&D

Cerevance To Focus On Parkinson’s Adjunctive Therapy After Phase II Miss

 
• By 

After failing a Phase II monotherapy study in early Parkinson’s, Cerevance will focus on adjunctive therapy without abandoning the monotherapy concept.

Baxdrostat, AstraZeneca’s Next Big CVRM Bet

 
• By 

The firm has lofty ambitions for the aldosterone synthase inhibitor to treat hypertension and kidney disease.

Merck’s Winrevair Slashes Morbidity-Mortality Risk For PAH Patients

 

The ZENITH study is a landmark for Merck’s first-in-class activin signalling inhibitor and pulmonary arterial hypertension treatment.