The US Food and Drug Administration (FDA) grants full approval to Lecanemab, the monoclonal antibody drug, for slowing down disease progression in adult patients diagnosed with Alzheimer's disease.

Alzheimer's disease progressively destroys memory and thinking skills, eventually impairing the ability to carry out simple tasks. It is an irreversible brain disorder characterised by changes in the brain, such as the formation of amyloid beta plaques and neurofibrillary tangles (tau), which lead to the loss of neurons and their connections. Drugmakers Eisai and Biogen have developed the Alzheimer's drug Lecanemab, marketed as Leqembi, which is administered intravenously every two weeks. This drug will be available for individuals diagnosed with early-stage Alzheimer's and those with mild cognitive impairment, a pre-Alzheimer's condition.

Although the drug does not cure Alzheimer's, it has demonstrated the ability to decrease the rate of disease progression and slow down cognitive and functional decline in adults diagnosed with Alzheimer's disease. Teresa Buracchio, the acting director of the Office of Neuroscience in the FDA's Center for Drug Evaluation and Research, said -

"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."

The FDA stated that the drug has the potential to induce brain swelling or bleeding, which typically ranges from mild to moderate and resolves spontaneously, although in rare instances, it can be severe and even fatal. As a precautionary measure, the regulatory authority has instructed the companies to include a "black-box warning" on the drug's label, signifying the highest level of urgency. The warning highlights that the medication can lead to "serious and life-threatening events".

The FDA indicated that individuals at higher risk of adverse effects from the drug include those taking blood thinners, those with a history of more than four microscopic brain bleeds, and those carrying a specific Alzheimer's-associated gene mutation known as APOE4, particularly if they possess two copies of the mutation. It has been reported that the expected cost of the drug for a standard year's treatment, without insurance, is approximately $26,500.

Resource - https://www.medindia.net/news/lecanemab-alzheimers-drug-approved-for-slowing-disease-progression-212617-1.htm