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Summary
- Biogen has received accelerated approval from the Food and Drug Administration (FDA) for its Alzheimer’s disease (AD) treatment, aducanumab.
- The clinical trials results demonstrate that aducanumab reduced amyloid-beta plaques by 59-71% at 18 months of treatment.
- Furthermore, Biogen will conduct a controlled trial to confirm the clinical benefit of aducanumab in patients with AD.
- Biogen and Eisai are committed to not raising the price of this new Alzheimer’s drug for the upcoming four years.
In a historic, yet somewhat controversial development, Biogen (NASDAQ:BIIB) and Eisai Co Ltd announced that the US Food and Drug Administration (FDA) had granted accelerated approval for Biogen’s ADUHELM™ (aducanumab-avwa). ADUHELM™ is the first and only AD treatment to address a defining pathology of the neurodegenerative disease by reducing amyloid-beta plaques in the brain.
Aducanumab brings much-awaited hope for patients and families who have Alzheimer’s disease as it is the first new treatment for the neurological condition to be authorised by the US FDA in nearly 20 years.
Source: © Rfaizal707 | Megapixl.com
Following the historical news, Biogen’s share price skyrocketed and closed the trading session at US$395.85, up by 38.34% on the NASDAQ on 7 June 2021.
The Company disclosed that the accelerated approval was granted on the basis of data from clinical trials demonstrating the effect of aducanumab in the reduction of amyloid-beta plaques. Amyloid-beta plaque is a biomarker for clinical benefit prediction – a reduction in clinical decline in this case.
Michel Vounatsos, CEO of Biogen, commented:
The Company disclosed that the efficacy of aducanumab was assessed in two Phase 3 clinical studies-
Copyright © 2021 Kalkine Media (Source: Biogen update, 7 June 2021)
In these studies, aducanumab consistently indicated a dose as well as time-dependent effect on reducing the amyloid-beta plaques by 59-71%.
Furthermore, as a part of the accelerated approval, Biogen will conduct a controlled trial for the verification of ADUHELM clinical benefit in patients with AD.
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Biogen, Eisai launch several initiatives to support patient access to aducanumab
Following the accelerated approval of aducanumab, Biogen and Eisai announced multiple programs to support access for all qualified patients, including the patients who belong to traditionally underserved populations. Notably, these initiatives aim to assist patients and their families understand the disease, navigate the diagnostic journey, and afford treatment.
Biogen and Eisai have been working diligently with payers to arrange the launch of ADUHELM and support patient access. The two companies are committed to not raising the price of ADUHELM for the next four years.
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