The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 23 October 2024, approved a licence for the medicine donanemab (Kisunla) for use in the early stages of Alzheimer’s disease, following a thorough review of the benefits and risks.
Donanemab works by removing a sticky protein called beta-amyloid from the brain that is believed to cause Alzheimer’s disease, and in the trials conducted the medicine showed some evidence of efficacy in slowing its progression.
The decision was made with expert scientific advice on the benefit risk of donanemab from the Commission on Human Medicines (CHM), the government’s independent advisory body.
Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access, said: “Licensing medicines which meet acceptable standards of safety, quality and efficacy is a key priority for us.
“We’re assured that, together with the conditions of the licence approval, the appropriate regulatory standards for this medicine have been met.
“As with all medical products, we will keep its safety under close review, and with a safety study to be undertaken after licensing, we will ensure that the benefit risk of donanemab is closely followed up post-authorisation.”
Donanemab is approved to treat adults in the early stages of Alzheimer’s disease who have one or no copies of the apolipoprotein E4 gene (ApoE4).
A person can have no copies, one copy or two of this gene.
Approximately 15 per cent of those diagnosed with Alzheimer’s disease have two copies of this gene, known as homozygous patients, and are at increased risk of developing Alzheimer’s disease, while people with one copy also have an increased risk.
The patient’s doctor will perform testing to make sure that donanemab is right for them.
As with any medicine, the MHRA will keep the safety and effectiveness of donanemab under close review.
To promote safe and effective use and keep the safety and efficacy of donanemab under close review, initiation of treatment in any patients will be through a central registration system implemented as part of a controlled access programme.
