Drug licence refused

A decision by the European Medicines Agency (EMA) to refuse a licence for the dementia drug aducanumab has been described as “bitterly disappointing news for people with Alzheimer’s disease.”

Alzheimer’s Research UK chief executive Hilary Evans made the comment after the EMA rejected an application by the manufacturer Biogen to distribute the drug across the European Union.  It is not known whether Biogen will make a similar application to the UK regulator, the MHRA, to license the drug here.

The EMA turned down the application despite the fact that aducanumab – known commercially as Aduhelm – has been approved for use in the USA for people with mild cognitive impairment or mild Alzheimer’s disease.

In its ruling the agency agreed that the drug does reduce Alzheimer’s trademark amyloid protein in the brain but said that the link between this and clinical effect was unproven. Nor did the studies show the drug was sufficiently safe since there was evidence in some cases of brain swelling or bleeding.

Evans added: “Biogen must continue collecting essential data to clarify the safety and effectiveness of aducanumab.  While further data collection is happening in the US, the UK is uniquely well placed to deliver world-class clinical studies that could address unanswered questions about the drug.”

Similar Posts

  • Barbara Pointon MBE

    A musical celebration of the life of Barbara Pointon MBE will be held in Cambridge on 25 September.  Barbara became well known in the late 1990s when ITV showed the documentary Malcolm and Barbara: A Love Story, about how she cared for her husband who had dementia.  She became a high profile campaigner on dementia…

  • More ‘Knowledge is Power’ resources available 

    Having signposted to ‘Knowledge is Power’ resources previously https://journalofdementiacare.co.uk/a-trio-of-knowledge-is-power-resources-available, we’ve noted that further additions to these resources are now available.  You can download a Scottish Gaelic ‘Knowledge is Power’ Booklet here: https://www.dementiavoices.org.uk/wp-content/uploads/2021/04/Knowledge_is_Power_Scottish_Gaelic_booklet_single_A5_pages_AW.pdf and a Welsh booklet here: https://www.dementiavoices.org.uk/wp-content/uploads/2023/10/Knowledge-is-Power-cy.pdf (via DEEP: https://www.dementiavoices.org.uk/deep-resources/knowledge-is-power/).  Via Bangor University / Dementia Services Development Centre (DSDC) Cymru/Wales https://dsdc.bangor.ac.uk/products-created.php.en you can access: …

  • Brain injury and sport

    Nearly 400 former football and rugby professionals were due to file legal claims on Tuesday 5 April for brain injuries that have resulted in cases of young onset dementia.  Included among the 378 claimants are 100 former rugby league players, 40 former rugby union players and 14 former footballers, who allege that the games’ governing…

  • Nominations open for the Markel 3rd Sector Care Awards 2025 

    The Markel 3rd Sector Care Awards 2025 has opened for nominations.  The organisers say:  “These Awards are designed to reward the hard work, dedication, innovation and excellence of everyone working in the not-for-profit sector who is making a positive difference to people’s lives, whether they are supporting children or adults.”  Nominations close on 25 October…

  • Forthcoming book from Emma Heming Willis

    Bruce Willis’ wife, Emma, has announced plans to publish a book (currently untitled) in 2025 about her experiences as a carer to Bruce who lives with frontotemporal dementia.  Emma said of her experiences of her husband’s dementia diagnosis:  “For many people, their first touch point about this disease is received in their doctor’s office. I…

  • Participants wanted to trial Snapshot Boxes

    Researchers from the University of Suffolk are looking for 25 people to trial Snapshot Boxes in social care settings.  Snapshot Boxes, created by Suffolk firm Chronicle, are photo frames that play voice recordings, enabling a person with dementia to view photos alongside the voices of loved ones.  The trial is part of a six-month research project,…