Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Aduhelm Observational Study Will Spur Debate On Utility of Real-World Evidence For mABs In Alzheimer’s

Executive Summary

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.

You may also be interested in...



Medicare Coverage Analysis Of Alzheimer’s Drugs Begins With Focus On Outcomes, Patient Eligibility

Proposed reimbursement decision to be released by 12 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.

Aduhelm Approval Firestorm Raises Question: What Are US FDA Advisory Committees For, Anyway?

After three panel members resign over agency’s approval of Biogen’s Alzheimer’s disease drug, the ‘billion-dollar question’ is why FDA provided so little information to justify use of beta amyloid as a surrogate endpoint, one panelist asserts, especially since the agency expressly disavowed the pathway during the advisory committee meeting.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS144774

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel