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


Eisai/Biogen’s Leqembi Breezes Through Adcomm, Labeling Discussions With US FDA May Be Knottier

Executive Summary

To get traditional approval, the Alzheimer’s treatment could see tightened labeling on the need to test for ApoE ε4 status given advisory committee recommendations. Some panelists also raised concerns around use with anticoagulants and in patients with cerebral amyloid angiopathy.

You may also be interested in...

Eisai/Biogen’s Leqembi: US FDA’s Full Approval Comes With A Boxed Warning On ARIA Risk

Labeling for the first anti-amyloid to receive traditional approval in Alzheimer’s disease states that testing for ApoE ε4 status ‘should be performed’ prior to treatment; updated labeling also includes stronger cautionary language on use in patients with risk factors for cerebral hemorrhage.

Medicare’s Alzheimer’s Drug Registry: Ease Of Use May Lead To Data Quality Tradeoffs

New details from CMS about the information that providers will be required to submit for Medicare beneficiaries taking anti-amyloid Alzheimer’s drugs indicate the agency could have a hard time getting answers to some of the key questions outlined in its National Coverage Determination.

How Much Delay In Alzheimer’s Disease Progression Is Clinically Meaningful?

US FDA agrees with Eisai/Biogen that half a point change in cognitive scale, which sponsor says means a five month delay in decline, is a clinically meaningful benefit. But others contend the treatment effect is small and does not outweigh risk of brain bleeds.

Related Content


Related Companies

Latest Headlines
See All



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