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

Leqembi Safety Is Focus Of Three Postmarketing Requirements From US FDA

Executive Summary

Required studies will assess the risks of ARIA and intracerebral hemorrhage, as well as safety in ApoE ε4 homozygotes. For the required registry-based study, the FDA suggests use of the ALZ-NET platform with no mention of CMS’ newly established registry, which may lack the level of detailed information needed to satisfy the drug regulator’s request.

You may also be interested in...



Lingering Leqembi Question: When Should Treatment Stop?

Several questions about the anti-amyloid product used to treat Alzheimer’s remain, which could affirm calls for more US FDA, CMS and NIH collaboration on research.

New Model For Real World Evidence? Leqembi Registry Data Will Be Bolstered By Medicare Claims

Senior Centers for Medicare and Medicaid Services official Lee Fleisher described the game plan behind the CMS-facilitated patient registry for the new Alzheimer’s disease treatment, but former CMS official Sean Tunis is still concerned the approach won’t meet data expectations in the planned two-year window.

After Leqembi Approval, US FDA In No Rush To Declare Amyloid A Validated Surrogate Endpoint

Ability to use beta amyloid plaque reduction to support a traditional approval in Alzheimer’s, or for use with other drug classes, needs to be evaluated case-by-case based on the available data, agency says. In the HIV/AIDS space, it took FDA decades to declare a surrogate endpoint validated.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS148510

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