There’s another glimmer of hope for early Alzheimer’s disease patients and their families. Eli Lilly reports positive results from a Phase 3 study of its drug donanemab.
In the trial, 47% of patients who took the drug saw the progression of Alzheimer’s stop for one year. Twenty-nine percent of patients taking a placebo, however, achieved the same results.
According to the researchers conducting the trial, participants taking donanemab saw little decline in their ability to carry out many functions of daily life. Based on the results, the company said it will move forward to seek regulatory approval from the U.S. Food and Drug Administration (FDA).
Donanemab is a therapy that targets amyloid plaque in the brain. Many scientists believe the buildup of that material is one of the main causes of the progressive memory loss associated with the disease.
The study was made up of people with early symptomatic Alzheimer's disease, which includes mild cognitive impairment (MCI) and the mild dementia stage of the disease. Participants completed their course of treatment with donanemab once they reached a prespecified level of amyloid plaque clearance.
‘Not a cure’
“It’s not a cure, but it is a significant step forward,” Eli Lilly CEO David Ricks told CNBC. “It significantly slows the disease down. Half the patients were off the drug after one year. That’s another feature of this drug, treat for a short period of time, get the benefit for a longer time.”
People who have followed Alzheimer’s disease research are well aware that there have been a number of promising developments over the years that didn’t pan out – or at least, haven’t so far. That said, the Alzheimer’s Association issued a statement welcoming the news and expressed hope.
The group called Lilly’s results “significant” and said they underscore the scientific evidence and personal benefit these types of treatments can have when people can get access to them. The association’s CEO, Joanne Pike, said the Centers for Medicare & Medicaid Services (CMS) policy to block Medicare access to FDA-approved Alzheimer's treatments is in “stark contrast to scientific evidence.”
Ricks expressed confidence that donanemab would win FDA approval and would become a primary way that doctors attack Alzheimer’s disease.
“Beta amyloid removal is a key to slowing down this disease,” Ricks said. “It’s not the only thing to do, but we have a new tool today.”