Biogen's recent achievement in securing EU approval for Aduhelm has marked a significant stride in the treatment of Alzheimer's disease.
This milestone not only reflects the company’s commitment to tackling neurodegenerative diseases but also brings renewed hope to millions of patients and families affected by Alzheimer’s across Europe.
What Is Aduhelm?
Aduhelm (aducanumab) is a therapy by Biogen for early-stage Alzheimer’s that reduces amyloid-beta plaques in the brain.
Unlike symptomatic treatments, it targets a key pathological feature believed to drive disease progression.
What Does EU Approval Signify?
The EMA’s approval recognises the urgent need for innovative Alzheimer’s treatments after Aduhelm’s controversial US FDA nod in 2021.
It opens Europe’s large patient base to a therapy shown to slow cognitive decline in early-stage Alzheimer’s.
The Impact on Patients
Aduhelm offers hope of maintaining cognitive and functional abilities longer for those diagnosed early.
Access, pricing, and healthcare readiness will shape how patients benefit in real-world settings.
Challenges Facing Aduhelm in Europe
Pricing and Cost Considerations
Aduhelm’s high price poses affordability challenges for national healthcare systems and patients.
Public and Medical Trust
Biogen must rebuild confidence after US approval debates by sharing transparent data and benefits.
Healthcare System Preparedness
Infusion centres and trained staff are needed to manage regular IV treatments and monitor side effects like ARIA.
Patient Eligibility and Diagnostics
Early-stage Alzheimer’s diagnosis varies across countries, impacting timely patient access to treatment.
Biogen’s Approach Moving Forward
Biogen is partnering with providers to build infusion centres and collaborating on fair pricing models.
Education campaigns and additional clinical evidence aim to reinforce Aduhelm’s real-world efficacy.
A Pivotal Point in Alzheimer’s Treatment
The EMA approval marks progress against a disease long seen as unstoppable and cements Biogen’s neurological leadership.
Success now depends on stakeholders working together to make this treatment accessible where it’s needed most.
