The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 23 October 2024, approved a license for the medicine donanemab (Kisunla) for use in the early stages of Alzheimer’s disease, following a thorough review of the benefits and risks.
Medicines and Healthcare products Regulatory Agency Oct 26 2024 The Medicines and Healthcare products Regulatory Agency has today, 23 October 2024, approved a license for the medicine donanemab for use in the early stages of Alzheimer’s disease, following a thorough review of the benefits and risks.
We’re assured that, together with the conditions of the license approval, the appropriate regulatory standards for this medicine have been met. At week 76 of the study, patients treated with donanemab had statistically significantly less clinical progression in their Alzheimer’s disease compared to patients that were treated with the placebo. This was assessed by change in iADRS score from baseline. Patients with low to medium levels of tau protein showed 35% slowing of clinical progression which equated to 4.4 months of delay in disease progression.
Use of donanemab in patients who are on anticoagulants or have been diagnosed with cerebral amyloid angiopathy on MRI before starting treatment is contraindicated as the risks in these patients are considered to outweigh the benefits.
Apolipoprotein Brain Dementia Doctor Efficacy Gene Genes Healthcare Intracerebral Hemorrhage Medicine Placebo Protein
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