FDA approves first Alzheimer's drug that slows disease's progression.

This week, the US Food and Drug Administration fully approved Alzheimer’s drug Leqembi, making a significant advancement in the ongoing fight against Alzheimer’s disease.

The Centers for Medicare and Medicaid Services said Thursday that efforts are being made to expand drug coverage, promising a broadened and uncomplicated access to the treatment. An estimation of 1 million people in their early stages of the disease will benefit from the medicine. 

“Today’s action is the first verification that a drug targeting the underlying disease process of Alzheimer’s disease has shown clinical benefit in this devastating disease,” Teresa Buracchio, acting director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in an announcement.

“This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease.”

Leqembi received full regulatory approval only for people suffering from the early symptoms of Alzheimer’s disease, those with mild cognitive deficiency or mild impaired thinking whose brains are confirmed to have accumulated amyloid plaques.

According to the Alzheimer’s Association, more than 6 million adults aged 65 or more in the United States are diagnosed with Alzheimer’s disease. 

The treatment could “give people in the early stages of Alzheimer’s more time to maintain their independence and do the things they love,” Joanne Pike, president and CEO of the Alzheimer’s Association, said in a statement.

Leqembi, from Japanese drugmaker Eisai and U.S.-based drugmaker Biogen, is proven to be effective in targeting the so-called beta-amyloid, a protein in the brain believed to be one of the main causes of Alzheimer’s disease. 

Alzheimer’s disease is an irreversible, progressive brain disorder that gradually damages memory and thinking abilities and, eventually, the ability to carry out simple tasks. While the causes of this pathological condition are still unknown, scientists believe that a combination of age-related changes in the brain destroys brain cells and leads to the development of the disease.

 While it is a significant improvement in the history of modern medicine, concerns about its safety and side effects are raised.

About 13% of participants in a trial experienced brain swelling or bleeding, and those risks could be higher for certain patients based on their genetics and medication.