MercoPress. South Atlantic News Agency

Brazil's sanitary watchdog greenlights drug to treat Alzheimer's

Anvisa will monitor the safety and effectiveness of donanemabe under strict scrutiny

Brazil's National Health Surveillance Agency (Anvisa) has approved the use of the drug donanemabe to slow the progression of Alzheimer's disease in patients with mild cognitive impairment and mild dementia. It works by targeting beta-amyloid plaques in the brain, which are associated with the malady.

A study with 1,736 patients showed that those receiving donanemabe had statistically significantly slower disease progression compared to those given a placebo. Marketed under the brand Kisunla, the drug is not recommended for patients on anticoagulants or those with cerebral amyloid angiopathy due to safety concerns.

“In Alzheimer's disease, clumps of beta-amyloid protein form plaques in the brain. donanemabee acts by binding to these clusters and reducing them, thus slowing down the progression of the disease,” Anvisa explained.

The agency's study analyzed changes in the cognitive condition and brain function of patients who received 700 milligrams (mg) of donanemabee every four weeks for the first three doses and then 1,400 mg every four weeks (for 860 patients) or placebo (a dummy infusion for 876 patients) for up to 72 weeks.

“At week 76 of the study, patients treated with donanemabe showed less and statistically significant clinical progression in Alzheimer's disease compared to patients treated with placebo,” Anvisa pointed out.

The use of donanemabe is contraindicated in patients who are taking anticoagulants, including warfarin, or who have been diagnosed with cerebral amyloid angiopathy (CAA) on magnetic resonance imaging before starting treatment. The risks in these patients, according to the agency, are considered to outweigh the benefits.

The most common adverse reactions listed by Anvisa are related to the infusion, which can cause fever and flu-like symptoms, as well as headaches.

“As with any medicine, Anvisa will monitor the safety and effectiveness of donanemabe under strict scrutiny. Risk minimization activities will be implemented for donanemabee, in accordance with the approved Risk Minimization Plan,” it was explained.

Alzheimer's disease is a progressive and fatal neurodegenerative disorder manifested by cognitive and memory deterioration, progressive impairment of activities of daily living, and a variety of neuropsychiatric symptoms and behavioral changes.

The disease begins when the processing of certain proteins in the central nervous system goes wrong. Toxic fragments of badly cut proteins then appear inside the neurons and in the spaces between them.

As a consequence of this toxicity, there is a progressive loss of neurons in regions of the brain such as the hippocampus, which controls memory, and the cerebral cortex, which is essential for language and reasoning, memory, recognition of sensory stimuli, and abstract thought.

“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 older people, accounting for more than half the cases of dementia in this population,” Brazil's Health Ministry said.

In Brazil, reference centers of the Unified Health System (SUS) offer free comprehensive multidisciplinary treatment for Alzheimer's patients, as well as drugs that help slow down the progression of symptoms.

“The care given to people with Alzheimer's, however, must take place on a full-time basis. Caregivers, nurses, other professionals, and family members, even outside the environment of reference centers, hospitals, and clinics, can take care of details relating to food, the environment, and other aspects that can improve the quality of life of patients,” the Ministry also noted. (Source: Agencia Brasil)