Today, 26 July 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended refusing the marketing authorisation for lecanemab 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 could be refused marketing authorisation by the EMA since aducanumab in December 2021. The EMA is the medicines regulator which assesses the safety and quality of new medicines across the 27 EU Member States plus Iceland, Norway, and Liechtenstein. The CHMP is the committee of the EMA responsible for determining the safety and efficacy of new medicines and plays a important role in determining the authorisation of medicines by the EMA.
Following the meeting, the CHMP posted the following information on their website relating to their decision:
The CHMP recommended not granting a marketing authorisation for Leqembi (lecanemab), a medicine intended for the treatment of Alzheimer’s disease. The committee considered that the observed effect of Leqembi on delaying cognitive decline does not counterbalance the risk of serious side events associated with the medicine, in particular the frequent occurrence of amyloid-related imaging abnormalities (ARIA), involving swelling and potential bleedings in the brain of patients who received Leqembi.
On the news ADI CEO, Paola Barbarino said:
Today’s announcement will undoubtedly be disappointing for our community and for those living with dementia across Europe. As this therapy is now approved in many regions of the world, the US, China and Japan to name a few, we at ADI are concerned that it could create a situation where those who are eligible and who can afford it could travel to receive treatment, whereas the rest of the population could not. We did write to the EMA earlier this year to express such concern. While today’s news is a setback, we are encouraged by the significant investment in research and innovation in this sector and we remain hopeful that new disease modifying treatments will soon become available to eligible Europeans to treat the condition.
We will continue to provide further information on this process, including the final decision by the EMA as and when it becomes available.
