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FDA leaders offer perspective on accelerated approval of Biogen’s Aduhelm

Leaders maintain that Aduhelm fits into the regulatory paradigm of the FDA’s accelerated approval pathway

In a viewpoint posted on JAMA Network, US Food and Drug Administration (FDA) leaders have offered their perspective on the controversial approval of Biogen’s Aduhelm for the treatment of Alzheimer’s disease. 

Billy Dunn, director of the FDA’s office of neuroscience, Peter Stein, deputy director of new drugs at the FDA’s Centre for Drug Evaluation (CDER) and Patrizia Cavazzoni, director of the CDER, wrote the article to explain the rationale for the FDA’s decision to grant Aduhelm (aducanumab) an accelerated approval.

In the post, they explained that although evidence from the Aduhelm programme was suggestive of clinical benefit, they came to the conclusion – alongside the FDA’s Peripheral and Central Nervous System Advisory Committee – that the trial data was not adequate to ‘convincingly demonstrate’ a clinical benefit in reducing clinical decline for Alzheimer’s patients.

Despite coming to this conclusion, they said that Aduhelm fits into the regulatory paradigm of the FDA’s accelerated approval pathway.

In explaining the choice to approve Aduhelm via this pathway, the FDA leaders highlighted the seriousness of Alzheimer’s and the expectation that Aduhelm’s mechanism of action may provide meaningful benefit over available therapy.

They also noted that Aduhelm reduced amyloid-beta plaques in both phase 3 trials – this is a key pathological marker and defining characteristic of the disease.

“In listening sessions, we heard from patients and their families about the devastating toll the disease has taken and their desire for a treatment to stop or delay functional losses,” the authors wrote.

“Many made it clear that they are willing to accept the trade-off of some uncertainty about clinical benefit in exchange for earlier access to a potentially effective drug, which is the exact premise and intent of accelerated approval,” they added.

Earlier this week, the FDA’s acting commissioner Janet Woodcock called for an independent review into the agency’s approval of Aduhelm.

Woodcock has asked for the process for review of Biogen’s biologics licence application (BLA) for Aduhelm to be investigated. This will include an ‘ongoing focus on interactions’ between Biogen and FDA staff during the review process.

The independent review will aim to determine if any of those interactions were inconsistent with FDA policies and procedures.

Article by
Lucy Parsons

14th July 2021

From: Regulatory



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