FDA On What Aduhelm AdCom Got Wrong: Statistics, Investigational Drugs, Patient Perspective
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.
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US FDA’s new draft guidance on benefit-risk assessments for new drugs highlights cases where it can take into account broader public health implications than just the pros and cons calculus for the patients described in a drug's label. While not a new policy perse, it is one the agency seems to have only grudgingly employed in the past.
Survey of advisory committee members finds many believe an overwhelmingly negative vote should prevent a product approval. Survey was prompted by FDA accelerated approval of Alzheimer’s disease treatment Aduhelm despite overwhelming committee rejection.
A survey of advisory committee members finds many believe that an overwhelmingly negative vote should prevent a product approval.