3,189 Days: Aduhelm Phase IV Timeline Is Long Among Alzheimer’s Drugs And Other Accelerated Approvals
Pink Sheet and Trialtrove analyses show time given Biogen to complete confirmatory trial exceeds duration of most other late-stage trials of anti-amyloid compounds and is almost double the average time allocated for follow-up studies of novel accelerated approvals since 2016; runway could reflect expectations for a longer follow-up period or potential enrollment challenges.
You may also be interested in...
US FDA cites expected sophistication of specialty prescribers in explaining why a Risk Evaluation and Mitigation Strategy was not needed for the Alzheimer’s drug, even though Biogen had submitted one.
Aduhelm Observational Study Will Spur Debate On Utility of Real-World Evidence For mABs In Alzheimer’s
Biogen’s ICARE AD-US study will assess the effects of aducanumab prescribed in routine practice to 6,000 patients. The lack of a concurrent control arm has critics questioning the study’s utility, but others say it could provide useful data on patient subgroups who were underrepresented or excluded from clinical trials and inform as to ARIA risks.
US FDA is reviewing confirmatory trial data that suggest a ‘detriment in survival’ with Oncopeptides’ alkylating agent in relapsed/refractory multiple myeloma and may convene its Oncologic Drugs Advisory Committee to explore continued marketing for patients who received at least four prior lines of therapy.