Paresh Malhotra
Head of the Division of Neurology, Imperial College London; and Consultant Neurologist, Imperial College Healthcare NHS Trust.
The approval of Leqembi by the United States FDA is a major step. The ‘black box’ warning indicates the importance and potential severity of the side effects of the drug, which are linked to patients’ genetics and also whether they are taking blood thinners. The informed consent process will be critical to the prescription and delivery of Leqembi, and genetic testing will be part of that. All this will raise a number of issues for what may happen in the NHS, and if Leqembi is approved here, then services will need to be very carefully designed to provide assessment, careful and honest informed consent, regular infusions and monitoring scans, as well as dealing with the side effects of brain swelling and bleeding.