WASHINGTON DC – The Food and Drug Administration approved a new Alzheimer’s treatment called donanemab on Tuesday, clearing the way for the third addition to a new class of drugs aimed at slowing the brain’s decline in patients facing the early stages of the disease.
Branded as Kisunla by drugmaker Eli Lilly, donanemab’s approval follows years of setbacks and delays in getting the experimental Alzheimer’s treatment to market, despite promising clinical trial results.
Eli Lilly says the drug will be available within weeks following the approval.
“Kisunla demonstrated very meaningful results for people with early symptomatic Alzheimer’s disease, who urgently need effective treatment options. We know these medicines have the greatest potential benefit when people are treated earlier in their disease, and we are working hard in partnership with others to improve detection and diagnosis,” Anne White, president of Eli Lilly’s neuroscience arm, said in a news release.
The FDA previously rebuffed Eli Lilly’s request for accelerated approval last year, citing concerns about its long-term safety data. After Eli Lilly submitted more data to the FDA, the company said it expected the agency would decide on approval by the end of March.
That decision was delayed after the FDA scheduled an advisory committee to wrestle with questions over the drug’s safety issues and how effectiveness was measured in its trials. The panel ultimately voted unanimously last month in favor of the drug’s benefits outweighing its risks, for patients in the early stages of Alzheimer’s disease.
Donanemab is part of a class of Alzheimer’s treatments called anti-amyloid monoclonal antibodies, which work to combat the buildup of a protein in the brain called amyloid plaque that has been linked to Alzheimer’s disease.
The antibody in donanemab targets amyloid plaques that have built up in patients by binding to and removing them from the brain.
Patients in Eli Lilly’s trials were given intravenous donanemab infusions for around half an hour, every four weeks. Depending on brain scans measuring amyloid levels in the brain, patients were able to stop taking the drug after as early as six months.
In its trials, the company says almost half of patients were able to meaningfully clear out amyloid after around a year after taking the drug. Patients saw no “rebound of amyloid plaque” in the year after treatment wrapped up.
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