Luxembourg, 7 June 2021 – Today, the US Food and Drug Administration (FDA), in a highly anticipated decision by the global dementia community, authorised aducanumab for the treatment of Alzheimer's disease and asked Biogen to conduct a post-approval clinical trial to verify the drug's clinical benefit.
Alzheimer Europe welcomes the approval of the first treatment to modify disease progression, rather than provide symptomatic relief, as currently authorised medicines do. This decision constitutes a significant advance in the treatment of Alzheimer’s disease and gives hope to patients and their families that the cognitive and functional impairments associated with the disease may be slowed or delayed.
Alzheimer Europe also welcomes the decision by the FDA to ask for additional safety and efficacy data to be collected through a post-approval study, as the medicine is being rolled out to patients in the US, addressing concerns raised by the ambiguous results from the two Phase III trials conducted to date.
Alzheimer Europe stresses the need to communicate clearly on which patients will be eligible for treatment, as treatment will be limited to patients with mild cognitive impairment or mild dementia. Additionally, patients will need to have confirmed amyloid presence in their brain which will require a lumbar puncture or brain scan prior to initiating treatment. Regular MRI scans may be appropriate, in order to monitor potential side effects. Treatment eligibility, risks, benefits and costs should therefore be discussed in realistic terms.
European patients will however not receive access to this new treatment yet, as the drug is currently undergoing a full evaluation by European regulators, including the European Medicines Agency or Swissmedic where applications were submitted in October 2020 and April 2021 respectively. Decisions by European regulators are not expected before the end of the year, but Alzheimer Europe hopes for a similarly positive outcome at European level.
Once aducanumab has been approved by the European regulators, pricing and reimbursement discussions will take place at national level and Alzheimer Europe and its national member organisations hope that countries will ensure that this innovative treatment will rapidly be available in all European countries and accessible for patients regardless of their socio-economic background or place of residence.
Whilst encouraged by this important progress in the treatment of people at the earlier stages of Alzheimer’s disease, Alzheimer Europe reiterates its call for continued research into other treatment options including symptomatic treatment for people in more advanced stages and preventative approaches throughout the lifecourse. In addition, Alzheimer Europe remains committed to a holistic approach to Alzheimer’s disease and other types of dementia where new treatment options are included alongside counselling, support and adequate care of people with dementia and their carers at all stages of the disease.
For further information, contact: Jean Georges, Executive Director, Alzheimer Europe, 14, rue Dicks, L-1417 Luxembourg, Tel.: +352-29 79 70, Fax: +352-29 79 72, jean.georges@alzheimer-europe.org, www.alzheimer-europe.org
Notes to editors:
Alzheimer Europe is the umbrella organisation of national Alzheimer associations and currently has 37 member organisations in 33 European countries. The mission statement of the organisation is to change perceptions, practice and policy to ensure equal access of people with dementia to a high level of care services and treatment options.
Declaration of interests: Alzheimer Europe had an audited income of EUR 1,322,672 in 2020. Sponsorship by the developing companies of aducanumab (Eisai and Biogen) amounted to EUR 60,272 or 3.55% of total income. Sponsorship by pharmaceutical companies is only accepted in accordance with the organisation’s Sponsorship guidelines and, in line with the European Medicines Agency criteria for patient organisations, declared in full transparency on the Alzheimer Europe website: https://www.alzheimer-europe.org/Alzheimer-Europe/Finances2/AE-Sponsors