Leqembi Safety: Label Has Distinct MRI Schedule But Follows Aduhelm On ARIA Management

 
• By Sue Sutter
  
Generate a summary of this article
Listen to this article
Beta

With the second amyloid-targeting antibody for treatment of Alzheimer’s, US FDA opted for a class-wide approach to management of amyloid-related imaging abnormalities, but with a product-specific MRI monitoring schedule that differs from that of Aduhelm.

Drug Review Profile: Leqembi
Leqembi and Aduhelm carry different schedules for MRI monitoring for ARIA. • Source: Pink Sheet/Shutterstock

When the US Food and Drug Administration granted accelerated approval to Eisai Co., Ltd. and Biogen, Inc.’s Leqembi (lecanemab-irmb), making it the second amyloid-targeting antibody indicated for Alzheimer’s disease, the agency opted for a class-wide approach to labeling on management of amyloid-related imaging abnormalities, albeit with a product-specific MRI monitoring schedule.

The agency also looked to the labeling of the first comer, Biogen/Eisai’s Aduhelm (aducanumab-avwa), for recommendations regarding continued dosing with...

Pink Sheet Podcast

Learn what's happening at the US FDA. On the go.

Derrick Gingery and the team bring you a weekly "Drug Fix".

SpotifyApple PodcastsWebsite

More from Drug Review Profiles

Akebia’s Vafseo: Japanese Postmarketing Data, Narrowed Indication Eased Liver Toxicity Worries

 
• By Sue Sutter

The Pink Sheet Drug Review Profile explores the US FDA’s approval of vadadustat to treat anemia in chronic kidney disease patients on dialysis. A complete response letter cited the risk of drug-induced liver injury, but postmarketing data from Japan reassured reviewers.

Vafseo Chronology: Complete Response Letter, Dispute Resolution And A Second-Cycle Approval

 
• By Sue Sutter

The Pink Sheet’s Drug Review Profile looks at the timeline behind the development and US FDA approval of Akebia’s Vafseo, a treatment for anemia in chronic kidney disease patients on dialysis.

The Next 340B Battle: Discount Duplication With Medicare Negotiated Prices

 
• By Cathy Kelly

Manufacturers likely will have to determine when to provide a 340B discount on a drug assigned a Medicare negotiated price under CMS guidance. PhRMA anticipates the job will not be easy.

More from Product Reviews

data

New EU Filings

 
• By Saba Afreen

<p>Executive Summary</p> <p>Zanidatamab, Jazz and BeiGene’s investigational treatment for biliary tract cancer, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.</p>

data

EU CHMP Opinions And MAA Updates

 
• By Saba Afreen

<p>Executive Summary</p> This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

EU Biosimilar Filings, Opinions And Approvals

 
• By Saba Afreen

<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>