Eli Lilly, a leading pharmaceutical company, announced that their novel Alzheimer's drug, donanemab, demonstrated significant success in slowing cognitive decline and improving daily functioning by over a third in a major clinical trial. The study involved patients with early symptomatic Alzheimer's disease. Based on these promising outcomes, the company intends to seek approval from the US Food and Drug Administration (FDA) by the end of June.
Donanemab functions by eliminating amyloid plaque buildups in the brain, a key characteristic of Alzheimer's disease. Despite some reported side effects and three deaths during the trial, Eli Lilly's chief scientific and medical officer, Dr. Daniel Skovronsky, emphasized the importance of balancing potential risks and benefits for each medication and disease. He highlighted that 47% of trial participants taking the drug showed no decline in a crucial cognitive measure over a year, as opposed to only 29% in the placebo group.
According to Skovronsky, this level of efficacy is unprecedented in Alzheimer's disease treatment. Over 6 million Americans suffer from Alzheimer's, with an estimated 1.7 to 2 million people over 65 in the early stages of the disease. While drug development for Alzheimer's has faced numerous setbacks, donanemab and other new drugs are providing hope for better treatment options.
Administered via monthly infusions, donanemab clears amyloid plaques so effectively that 52% of trial participants stopped taking the drug within a year, and 72% did so within 18 months. The patients' progress will continue to be monitored.
While the price for Leqembi stands at $26,500 per year, Skovronsky refrained from discussing potential pricing for donanemab until it receives FDA approval.
The clinical trial evaluated participants in two groups based on tau protein levels in the brain. In the group with intermediate tau levels, cognitive and functional decline slowed by 35%. Combining this group with participants who had higher tau levels resulted in a 22% reduction in decline. These findings have not yet been peer-reviewed or published in a scientific journal.
Eli Lilly previously sought accelerated FDA approval for donanemab but was denied in January due to insufficient data. With these new results, the company will pursue full approval, which should expand insurance reimbursement options for the medication. Another Alzheimer's drug, Leqembi, received accelerated FDA approval in January but is awaiting full approval for broader Medicare coverage.
