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FDA On What Aduhelm AdCom Got Wrong: Statistics, Investigational Drugs, Patient Perspective

 
• By Brenda Sandburg

After a searing advisory committee on aducanumab, FDA reviewers undertook an extensive effort to counter or discount the panel’s criticisms, newly released review documents show. Among the unusual moves by the agency was the citation of data from two investigational products, Lilly’s donanemab and Biogen/Eisai’s BAN2401, as evidence in support of aducanumab.

Alzheimer's
FDA answers critics in review documents for Alzheimer's disease drug Aduhelm • Source: Alamy

The advisory committee review of aducanumab in November was a bruising affair for the US Food and Drug Administration, with a near unanimous vote against the drug and several pointed remarks directed to the agency by panelists about what they saw as an overly collegial relationship with the sponsor. FDA’s subsequent decision to grant accelerated approval of the Alzheimer’s drug suggested that the agency basically ignored the advisory committee, but newly released documents show that reviewers actually engaged in an extensive effort to downplay and dispute the panel’s conclusions. 

The committee erred in endorsing the findings of FDA’s statistical reviewers, failed to consider the similar treatment effects on clinical...

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Real-Time Release Of CRLs Is US FDA’s Goal, Agency Leaders Affirm

 
• By Michael McCaughan

The US FDA says its release of complete response letters for products subsequently approved by the agency is just a first step toward releasing rejection letters when they are issued, assuming legal issues can be resolved.

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