Aduhelm’s ‘Complex’ Circumstances Drove Extensive In-House Advice Process Before Accelerated Approval, Cavazzoni Says
Accelerated approval was considered as option in response to the negative advisory committee vote, but it was not a ‘default,’ CDER officials say. ‘It fit like a glove.’
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Alzheimer’s drug’s failure to meet Phase II endpoint did not preclude accelerated approval in light of statistically significant reduction in amyloid plaque and ‘generally consistent and favorable results on clinical endpoints.’ Size of six-month safety database also fell shy of ICH guidelines.
Without directly referencing the agency’s controversial approval of Biogen’s Alzheimer’s drug Aduhelm, CDER director Patrizia Cavazzoni defended US FDA’s ability to decide on use of the expedited pathway during an application review, while also stressing the need for earlier planning on evidence generation and confirmatory trials.
There is certainly some logic to directing the US FDA to create a council of top managers to assure that the Accelerated Approval pathway is used consistently. But it sure sounds like exactly what the agency did with Aduhelm.