The FDA authorizes Eli Lilly's Alzheimer's medication, increasing treatment alternatives in the U.S.

• The FDA approved Eli Lilly's Alzheimer's drug donanemab, increasing the limited treatment options for the disease.
• After facing several delays, Eli Lilly has finally achieved a long-awaited win with donanemab.
• After three decades of unsuccessful attempts to develop Alzheimer's medications, Donanemab and Leqembi from Biogen and Eisai represent significant advancements in the treatment of the disease.

The Food and Drug Administration approved 's Alzheimer's drug donanemab on Tuesday, increasing the limited treatment options for the disease in the U.S.

According to the company, the treatment approved by the agency for adults with early symptomatic Alzheimer's disease will be sold under the brand name Kisunla.

Almost 13 million Americans will have the condition, the fifth-leading cause of death for adults over 65, by 2050, according to the Alzheimer's Association.

After facing obstacles in its journey to market, Eli Lilly has finally secured a long-awaited win with donanemab. The FDA initially rejected the drug's approval last year due to insufficient data, and then delayed it again in March. However, an advisory panel to the agency recommended the treatment for full approval earlier this month, stating that the benefits of the treatment outweigh its risks.

Donanemab will face off against Leqembi, a treatment from Biogen and Eisai that has been gradually released in the U.S. since gaining approval last summer.

Eli Lilly's drug is the third to hit the market after Leqembi and the failed therapy from Biogen and Eisai, Aduhelm, which was recently dropped by the companies. Despite a negative recommendation from an advisory panel, the FDA approved Aduhelm in 2021, sparking criticism.

After three decades of unsuccessful attempts to develop Alzheimer's medicines, Donanemab and Leqembi have emerged as milestones in the treatment of the disease. These drugs are monoclonal antibodies that target toxic plaques in the brain called amyloid, a hallmark of Alzheimer's, to slow the progression of the disease in patients at the early stages of it.

Drugs that target and clear amyloid plaque can also pose significant safety risks, including severe and fatal brain swelling and bleeding.

In a late-stage trial, three patients who took Eli Lilly's drug died from severe forms of amyloid-related imaging abnormalities (ARIA).