1. Pink Sheet
  2. >>Product Reviews

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

 
• By Neena Brizmohun

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).
  • Eisai is to seek a re-examination of the CHMP opinion and said it would work with the relevant authorities to ensure its treatment was available in the EU as soon as possible

The rejection was announced by the EMA today, after the agency’s human medicines committee, the CHMP, adopted a negative opinion for the drug, saying that the benefits of the treatment

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Product Reviews

Keep Talking: US FDA’s Beleaguered Biologics Center Remains Vital To Regenerative Medicine

 
• By Bridget Silverman

Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.

Recent and Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

US FDA Advisory Committee Misperceptions Abound … At HHS

 
• By Michael McCaughan

HHS Secretary Robert F. Kennedy Jr. regularly decries the “conflicts of interest” he believes abound in advisory committees, but his concerns, as well as a recent “policy directive” eliminating industry representatives, seem driven by a misunderstanding of the panels’ jobs.

US FDA Layoffs Hit Conflict-Of-Interest Screening For ODAC Meeting

 
• By Sue Sutter and Derrick Gingery

Screening for conflicts and finding the right expertise for a two-day Oncologic Drugs Advisory Committee meeting on four products has been complicated by the Trump Administration’s initial communications freeze and subsequent layoffs in CDER.

More from Pink Sheet

Pink Sheet Podcast: A New Director For US FDA’s Biologics Center, Guidance Production Slowdowns

 
• By Derrick Gingery, Sue Sutter, and Nielsen Hobbs

Pink Sheet editors discuss the appointment of Vinay Prasad as the new director of the Center for Biologics Evaluation and Research and revelations that FDA layoffs now are hindering development of guidance documents.

US FDA Restoring Some Library Resources

 
• By Sue Sutter and Derrick Gingery

Agency staff once again have access to the Lexis-Nexis legal and news database, but are still waiting for access to journals, and laid off librarians have not been reinstated.

Recent and Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.