Alzheimer's patients and their relatives had high hopes that the braking medicine Leqembi would be approved in the EU for the treatment of early Alzheimer's disease. But as a cold shower in the middle of the summer, the EMA said no.
Now the medicine is getting permission in the UK, for certain patient groups, writes the company Bioarctic in a press release. For example, it will not apply to patients with a double set of the Alzheimer's risk gene ApoE4, which is about 10-15 percent of patients.
It also seems very unclear whether the medicine will be subsidized by the British healthcare system NHS.
According to the EMA's decision in July, Leqembi indeed affects the underlying causes of Alzheimer's, but the effect was small on patients' symptoms and disease progression. The health benefit is not sufficient in relation to potential drawbacks and side effects, such as swelling and risk of bleeding in the brain, according to the EMA.
With roughly the same reasoning, the British authority Nice assesses that the medicine will not be subsidized.
The medicine has previously been approved in, among other countries, the USA, Japan, and China. The Swedish company Bioarctic, which is behind the discovery that forms the basis for the medicine, has requested a review of the EMA's decision.
