Accelerated Approval Of Lilly’s Alzheimer’s Drug Could Last About 15 Months, CEO Says
Lilly expects results from donanemab ongoing confirmatory trial in 2023, while Biogen has nine years to finish its postmarket study. CEO David Ricks discusses impact of aducanumab approval backlash, pricing and national coverage decision at STAT summit.
You may also be interested in...
Former CMS chief Mark McClellan discusses what kind of study requirements Medicare might impose if it decides to only cover the new Alzheimer’s drug if in the context of further evidence generation.
Proposed reimbursement decision to be released 1 January 2022, with a final decision the following April. Biogen's Aduhelm expected to be covered in the interim. Medicare will not consider the cost of treatment in the analysis, but cost may have been a factor in initiating the process.
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.