Aduhelm, One Year Later: US FDA’s Credibility, Accelerated Approval Pathway Feel The Bite From Alzheimer’s Drug Approval
June 7 marks the one-year anniversary of the accelerated approval of Biogen’s aducanumab, an event that still reverberates throughout the drug development community. While the FDA continues to defend the approval, experts say the backlash has caused the agency to become more reluctant to use the expedited pathway. Meanwhile, Alzheimer’s patients find themselves where they were a year ago: without ready access to a disease-modifying therapy.
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US FDA Says Confirmatory Trials Should Start Before Accelerated Approval But Is Not ‘Dogmatic’
Beginning confirmatory trials before the accelerated approval is granted shortens the time between clearance and the confirmation of benefit, when patients are at risk, said Oncology Center of Excellence Director Richard Pazdur.
Y-mAbs’ I-Omburtamab Offers Another Example Of The Limits To US FDA’s Regulatory Flexibility
Even in a rare disease with no approved treatments, the agency shows once again that without clear efficacy data, FDA has few options for approval.
The Moment Of Truth For Three Alzheimer’s Drugs Beckons: What To Expect
After the Aduhelm controversy, Eisai/Biogen, Roche and Lilly are lining up Phase III results for their candidates which, against the odds, they hope could finally represent real progress in Alzheimer’s treatment. Scrip takes a look at the key questions surrounding the field as the drugs await their fate.