Today, 28 March, the European Medicines Agency’s (EMA), expert advisory committee, the Committee for Medicinal Products for Human Use (CHMP) has recommended against the marketing authorisation of donanemab in the treatment of mild cognitive impairment or the mild dementia stage of Alzheimer’s disease.
This is the second monoclonal antibody for the treatment of Alzheimer’s disease that is likely to be denied marketing authorisation by the EMA, since aducanumab, leaving lecanemab as the only monoclonal antibody in the treatment of Alzheimer’s disease likely to be granted marketing authorisation within the EU and EEA.
Following the meeting, the CHMP posted the following information on their website relating to their decision:
The committee recommended not granting a marketing authorisation for Kisunla (donanemab), a medicine intended for the treatment of early Alzheimer’s disease. The committee considered that the benefits of this medicine were not large enough to outweigh the risk of potentially fatal events due to amyloid-related imaging abnormalities (ARIA), involving swelling and potential bleedings in the brain.
On the news, ADI CEO Paola Barbarino said:
Today’s decision will be deeply disappointing for people living with Alzheimer’s disease and their families across Europe. For many who cannot afford to travel to another country to get treatment this is a window that potentially closes on their hopes of getting treatment. The latest treatments only work at specific stages of the disease and for many that window has already closed.
As we write there are still no treatments available in Europe, however, treatments are available in the UK, China, Japan, South Korea, Israel, United Arab Emirates and the United States among others.
The disparity between regulator decisions is concerning, it is important that treatments for those living with dementia are safe, however with a timebound degenerative condition and the lack of choice and availability in Europe, we are concerned that this further increases the risk of health tourism for those who can afford it and denies access to those who can’t.
Health Tourism is an area ADI has recently been highlighting.
We believe that people everywhere should have the same opportunity to benefit from advances in research and disease modifying therapies. While this is a setback, we remain committed to advocating for better access to diagnosis, treatment, and care for all those living with dementia across the world.
ADI will continue to provide further information when it becomes available.
The EMA is the medicines regulator which regulates medicinal products and devices across the 27 EU Member States plus Iceland, Norway, and Liechtenstein. The CHMP is the committee of the EMA responsible for determining the safety, quality and efficacy of new medicines for human use and plays an important role in determining the authorisation of medicines by the EMA.