With the last approval of an Alzheimer’s medicine by the European Medicines' Agency (EMA) dating back to 2002, people living in Europe affected by Alzheimer’s disease have been waiting to gain access to better treatments for 20 years.
Biogen recently announced that it had notified the EMA about the withdrawal of its marketing authorisation application for aducanumab for the treatment of early Alzheimer’s disease, following discussions with the Agency’s Committee for Medicinal Products for Human Use (CHMP) during which the CHMP had indicated that there was insufficient scientific evidence to support the authorisation of aducanumab, and so the wait for innovative, disease modifying treatments continues in Europe.
Alzheimer Europe continues to monitor clinical trial developments with great interest and notes the welcome announcement by Biogen about the upcoming launch of a phase IV trial of aducanumab. The organisation hopes that this trial and ongoing trials by other companies will lead to positive results and to the approval by the EMA a new treatment against Alzheimer’s disease, after two decades of disappointments.
Alzheimer Europe also calls for continued research into much-needed and anticipated treatment options, including symptomatic treatments for people in more advanced stages of the disease. In addition, the organisation remains committed to a holistic approach to Alzheimer’s disease and dementia where treatment needs to be provided alongside counselling, support and adequate care of people with dementia and their carers throughout the disease process.