0
ANational Health Surveillance Agency (Anvisa) approved the registration of the drug Kisunla (Donanemabe), indicated for the treatment of mild cognitive impairment and mild dementia associated with Alzheimer’s disease. According to the entity, it is a monoclonal antibody that binds to a protein called beta-amyloid.
“In Alzheimer’s disease, beta-amyloid protein clusters form plaques in the brain. Donanemab acts by linking to these clusters and reducing them, thus slowing the progression of the disease,” explains Anvisa.
MEC will evaluate quality of medical courses annually/Photo: Reproduction
Also according to the agency, Donanemabe was evaluated in a study involving 1,736 patients with early -stage Alzheimer’s disease, who had mild cognitive impairment, mild dementia and evidence of amyloid pathology.
The study analyzed changes in the cognition and brain function of patients. They received 700 milligrams (MG) from Donanemab every four weeks in the first three doses and then 1,400 mg every four weeks (for 860 patients) or placebo (a simulated infusion for 876 patients) for up to 72 weeks.
“In week 76 of the study, patients treated with Donanemabe had smaller and statistically significant clinical progression in Alzheimer’s disease compared to patients treated with placebo,” said Anvisa.
Contraindication
The use of Donanemab is contraindicated in patients taking anticoagulants, including varfarin, or who have been diagnosed with brain amyloid angiopathy (AAC) in magnetic resonance imaging before starting treatment. Risks in these patients, according to the agency, are considered greater than the benefits.
Reactions
The most common adverse reactions listed by Anvisa are related to infusion, which can cause fever and flu symptoms, as well as headaches.
“As with any medicine, Anvisa will monitor Donanemabe’s safety and effectiveness under rigorous analysis. Risk minimization activities will be implemented for Donanemab in accordance with approved risk minimization plan.”
Alzheimer
The Ministry of Health defines Alzheimer’s disease as a progressive and fatal neurodegenerative disorder that manifests itself by cognitive deterioration and memory, progressive impairment of daily life activities and a variety of neuropsychiatric symptoms and behavioral changes.
The disease settles when the processing of certain central nervous system proteins begins to go wrong. Fragments of poorly cut, toxic proteins appear within the neurons and in the spaces that exist between them.
As a consequence of this toxicity, there is progressive loss of neurons in brain regions such as hippocampus, which controls memory, and cerebral cortex, essential for language and reasoning, memory, recognition of sensory stimuli and abstract thinking.
“The cause is still unknown, but it is believed to be genetically determined. Alzheimer’s disease is the most common form of neurodegenerative dementia in old people, being responsible for more than half of cases of dementia in this population,” says the ministry.
In Brazil, Reference Centers of the Unified Health System (SUS) offer free and free multidisciplinary treatment for patients with Alzheimer’s, as well as medications that help slow the evolution of symptoms.
“Care dedicated to people with Alzheimer’s, however, should occur full time. Caregivers, nurses, other professionals and family, even outside the environment of the reference centers, hospitals and clinics, can take care of details related to food, environment and other aspects that can raise the quality of life of patients.”
