The Food and Drug Administration has recently given its approval for Eli Lilly’s Alzheimer’s drug donanemab, marking a significant expansion in the treatment options available for individuals suffering from this debilitating disease in the United States. The approval of this drug, to be marketed under the name Kisunla, is a pivotal moment in the battle against Alzheimer’s, offering hope to the nearly 7 million Americans currently affected by the condition.

Alzheimer’s disease ranks as the fifth-leading cause of death among adults over the age of 65, with the number of cases projected to almost double to nearly 13 million by the year 2050. The approval of donanemab comes after a series of setbacks and delays faced by Eli Lilly in bringing the drug to market. Following a rejection last year due to insufficient data, the FDA unexpectedly postponed its approval once again in March. However, earlier this month, an advisory panel recommended the treatment for full approval, emphasizing the benefits it offers outweigh the associated risks.

Donanemab will now enter the market to compete directly with another Alzheimer’s treatment, Leqembi, developed by Biogen and Eisai. Both drugs represent significant milestones in the treatment of Alzheimer’s, following decades of unsuccessful attempts to develop effective medications to combat the disease. Donanemab and Leqembi are monoclonal antibodies designed to target toxic plaques in the brain known as amyloid, a key characteristic of Alzheimer’s, with the aim of slowing disease progression in patients during the early stages.

In clinical trials, Eli Lilly’s drug demonstrated a 35% reduction in Alzheimer’s progression over an 18-month period compared to a placebo. Patients were able to transition from the treatment to a placebo after meeting specific criteria for amyloid plaque clearance at six, 12, or 18 months. Administered through monthly infusions, the drug is estimated to cost $12,522 for a six-month course, $32,000 for 12 months, and $4…