FDA approves new drug to treat Alzheimer’s disease

The FDA has approved a news drug, Kisunla (donanemab-azbt), as a treatment for patients in the early stages of Alzheimer’s disease - UnSplash +

In trials, the drug was effective in helping patients with mild dementia

The U.S. Food and Drug Administration (FDA) has approved a news drug, Kisunla (donanemab-azbt), as a treatment for Alzheimer’s disease. The drug, administered as an injection, was approved for patients with mild cognitive impairment or mild dementia stage of disease.

Patients who receive the drug will get it as an intravenous infusion every four weeks. 

The drug efficacy was evaluated in a double-blind, placebo-controlled, parallel-group study in patients who had been diagnosed with Alzheimer’s disease. The patients had confirmed the presence of amyloid pathology and mild cognitive impairment or mild dementia stage of the disease. 

The FDA found that patients who were treated with Kisunla demonstrated a statistically significant reduction in clinical decline on the Integrated Alzheimer's Disease Rating Scale (iADRS) compared to placebo at Week 76. Patients treated with Kisunla also demonstrated a statistically significant reduction in clinical decline on the Clinical Dementia Rating Scale.

Alzheimer’s disease is an irreversible, progressive brain disorder affecting more than 6.5 million Americans that slowly destroys memory and thinking skills and, eventually, the ability to carry out simple tasks. 

While the specific causes of Alzheimer’s are not fully known, it is characterized by changes in the brain—including amyloid beta plaques and neurofibrillary, or tau, tangles—that result in loss of neurons and their connections. These changes affect a person’s ability to remember, think and speak.

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