Scrip is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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

Free Access To High-Cost Aducanumab May Incentivize Phase IV Trial Participants

Accelerated Approval Adds Another Alzheimer’s Study To Global Pipeline

Executive Summary

Experts say there should be enough Alzheimer’s patients willing to enroll in Biogen/Eisai’s US FDA-required Phase IV trial and other companies’ late-stage studies even with Aduhelm broadly available. 

You may also be interested in...



Doctors Frustrated By Lack Of Guidance On Who Should Get Aduhelm

Biogen has warned that uptake for its newly approved Alzheimer’s therapy will be slow in the beginning and doctors confirm it will take time to figure which patients can and should be treated.

Aduhelm Approval Is Breakthrough For Neurimmune, Company Which Discovered It

The co-founder of the Swiss company which discovered aducanumab looks back over its 20 year wait for approval, and ahead to future growth plans.

Aducanumab Accelerated Approval Reflects US FDA Flexibility But Raises Doubts About Confirmatory Trial

Biogen/Eisai Alzheimer’s drug wins agency nod on basis of amyloid plaque reduction, a surprising use of the accelerated approval pathway that was not considered by an FDA advisory committee; approval raises feasibility questions about confirmatory trial and daunting prospect of market withdrawal if studies fail to verify clinical benefit.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

SC144510

Ask The Analyst

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

Thank you for submitting your question. We will respond to you within 2 business days. 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