Reacción a "EMA recommends not approving donanemab for Alzheimer's"

This is very disappointing news. The EMA's decision again departs from that taken by other regulatory agencies such as the FDA in the US, as well as in Japan and China, which have authorised the treatment. Personally, I do not agree with the EMA's assessment of the risk-benefit ratio of donanemab. It seems to me to underestimate the clinically significant benefits demonstrated in trials and to overestimate the risks, which are well characterised and can be adequately managed in a controlled clinical setting.

More generally, I believe that this decision reflects a worrying situation in Europe, as recently described by Mario Draghi in his report on the challenges facing the continent. In the biomedical field, we continue to lose competitiveness and responsiveness vis-à-vis other regions of the world, with direct consequences for patients and innovation.