The European Commission has granted EU marketing authorisation for Kisunla, a medicine to treat mild cognitive impairment, including mild dementia in the early stages of Alzheimer’s disease.
Kisunla can help to slow down the progression of cognitive and functional issues associated with Alzheimer’s disease in certain patients. The authorisation is based on the positive scientific assessment of the European Medicines Agency, which concluded that the benefits of this medicine outweighed the risks for a specific population of early Alzheimer’s patients.
The authorisation decision sets strict conditions on the use of Kisunla, because it is only deemed suitable for patients with a particular genetic disposition. Clear risk mitigation measures, such as monitoring and labelling requirements, are also outlined.
The Commission decision will soon be available online.
Source: European Commission | Public health | Latest updates (https://tinyurl.com/439sa7er)