FDA Approves New Alzheimer’s Drug Targeting Beta-Amyloid

The U.S. Food and Drug Administration (FDA) has approved Eli Lilly’s new tab treatment for early Alzheimer’s. It is the second therapy available to U.S. patients that slows the progression of the brain-wasting disease. Donanemab is also known as Kisunla. It has been now approved for sale. Experts agree that it can be used to treat early Alzheimer’s disease because the benefits of the drug are greater than the risks. 

Donanemab is a drug that is designed to clear beta-amyloid from the brain. It is similar to Eisai and Biogen’s new tab drug Leqembi. This drug was approved a year ago. This is a significant advancement in the fight against Alzheimer’s.  

Patients with Alzheimer’s can take donanemab for a limited time. It is different because patients can stop taking it when brain scans no longer show amyloid plaques. 

One of the reputed neurologists, Dr. Erik Musiek says that monthly dosing of the drug can save patients significant money and make it an attractive option. But the details of its clinical practice are still unclear. 

Lilly conducted a big trial with donanemab to check its effectiveness. It showed that it can slow down memory and thinking problems by 29% compared to placebo. But some patients experienced some side effects such as brain swelling and brain bleeding. 

The FDA has issued a “boxed” safety warning for donanemab as it can increase the risk of brain swelling and bleeding. 

Eisai and Biogen are submitting data to the FDA for approval of a monthly IV infusion and a weekly injected version of Leqembi for Alzheimer’s treatment.  

Lilly’s drug is expected to be used mainly by patients aged 65 and older. Analysts predict that Lilly’s drug to generate over $5 billion in annual sales and compete with Biogen’s Leqembi. This will be very useful as over 6 million Americans have Alzheimer’s disease.