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The Food and Drug Administration Has Approved the New Alzheimer’s Drug Lecanemab

Lecanemab (sold under the brand name Leqembi), the new Alzheimer’s drug, was approved by the U.S. Food and Drug Administration (FDA) on January 6, 2023. Lecanemab has shown great promise in slowing cognitive decline and having a major difference in Alzheimer patients.

Alzheimer’s is a progressive disease and a type of dementia. Alzheimer’s affects memory; symptoms grow very severe and limit daily tasks. Alzheimer’s occurs when there is an abnormal build-up of proteins called amyloid and tau around the brain, but researchers don’t know what causes the build-up. 

Lecanemab was developed by pharmaceutical companies Eisai and Biogen. The drug is targeted towards the amyloid protein in the brain. Lecanemab is delivered by an intravenous therapy (IV) every two weeks. 

There was an ongoing clinical trial for the drug for 18 months. During the clinical trial, there were 1,800 adults ages 50 to 90 who had early Alzheimer’s. These participants received either lecanemab or a placebo. A placebo is a tablet that has no active ingredients and is taken because a drug can only be approved when it has a greater effect than the placebo. The results of the trial concluded that lecanemab had a good effect on the amyloid in the brain. Researchers also found that the participants who were administered lecanemab had significant slowing of cognitive decline. Researchers believe that these results show a great effect in the next step to curing Alzheimer’s and a great effect on the patients who have Alzheimer’s and their families. 

Although, there has been a significant amount of side effects. Some of the side effects are a reaction to the IV, bleeding or build-up of fluid in the brain, and headaches. Doctors have stated that patients who did have bleeding or build-up of fluid were mostly asymptomatic and were only detected by an MRI. There have also been three deaths that have occurred during the clinical trial, but researchers don’t know if lecanemab caused all of them.

Dr. Ronald Petersen, a neurologist and director of the Mayo Clinic Alzheimer’s Disease Research Center and the Mayo Clinic Study of Aging said that the drug is “pretty impressive” and that “the level of stabilization in the people who were treated with the drug is clinically meaningful.” Dr. Heather Snyder, the Alzheimer’s Association Vice President also said that “lecanemab can give people more time at or near their full abilities to participate in daily life, remain independent, and make future healthcare decisions.”

Image Source: Time


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