EU Blow For Alzheimer’s Drug Leqembi; Eisai To Appeal

 
• By Neena Brizmohun
  
Generate a summary of this article
Listen to this article
Beta

The EMA says the benefits of treatment with Leqembi are not large enough to outweigh its risks. Meanwhile, Alzheimer Europe is hoping that real-world findings from the US-mandated patient registry or from ongoing trials will help persuade the EU regulator to reconsider its position.

The Alzheimer’s disease drug Leqembi is already approved in the US, Japan, China, South Korea, Hong Kong and Israel • Source: Shutterstock

Eisai and Biogen are to appeal against the European Medicines Agency’s recommendation to refuse EU marketing approval for their Alzheimer’s disease (AD) drug Leqembi (lecanemab), which is already approved in the US, Japan, China, South Korea, Hong Kong and Israel.

Key Takeaways

  • The CHMP rejected Leqembi because it considered that the observed effect of the drug on delaying cognitive decline did not counterbalance the risk of serious side events associated with the medicine, in particular the frequent occurrence of amyloid-related imaging abnormalities (ARIA).

The rejection was announced by the EMA today, after the agency’s human medicines committee, the CHMP, adopted a negative opinion...

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 Product Reviews

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>

Stealth’s Elamipretide: Efficacy In Barth Syndrome Not Shown, US FDA Says

 
• By Sue Sutter

Cardiovascular and Renal Drugs Advisory Committee will consider whether open-label extension data from a randomized trial that failed its primary endpoint, along with a historical control comparison, are enough to support approval in the ultra-rare disease.

New EU Approvals

<p>Executive Summary<p> <p>The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, incl/ding Ixchiq, Valneva's chikungunya virus vaccine</p>

More from Pink Sheet

COVID Vaccines: US FDA Changes Course, Wants New Formulas To Target KP.2 Subvariant ‘If Feasible’

 
• By Sue Sutter

Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’

Nancy Tests New Podcast Template

 
• By Derrick Gingery

Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.

PinkSheet-R&D-Free: ‘Ranking’ article that includes different Composer content

 
• By Nabil, Olga Zviezdicheva, Reed Miller, Mary Jo Laffler, Ian Schofield, João Andrés-Ruíz de la Fontaine-LeBlanc, Chloë Anastasía-Stojanović del Castillo-Ribeirão, and Nabil

To make your document look professionally produced, Word provides header, footer, cover page, and text box designs that complement each other. For example, you can add a matching cover page, header, and sidebar. Click Insert and then choose the elements you want from the different galleries.