The FDA approved on Tuesday the donanemab drug for treatment of Alzheimer's disease.
The drug contains an antibody that aims to slow the progression of the incurable Alzheimer’s disease. It operates by eliminating the buildup of amyloid protein plaque in the brain.
According to the manufacturer, Lilly, the drug will be marketed under the name Kisunla and will cost $32,000 annually. Clinical trials have demonstrated that donanemab successfully slows the progression of Alzheimer's, allowing some patients to live independently for longer periods and continue daily activities.
In June, Lilly informed an FDA advisory committee that late-stage clinical trial data showed "very significant results" for patients taking donanemab. There was approximately 35% lower risk of disease progression over a year and a half compared to patients receiving a placebo. The FDA advisors concluded that the treatment appeared safe and effective.
Serious side effects
The company reported some serious side effects during the trials, occurring in about 2% of patients. Those taking donanemab had a slightly higher mortality rate of 2%, compared to 1.7% in the placebo group. Three individuals died while taking the drug after developing brain hemorrhages during the first six weeks of the trial. Consequently, the company added an additional brain MRI scan for patients which would identify the risk of brain haemorrhage early.
Lilly's drug is the second approved for early-stage Alzheimer’s treatment, following the approval of Leqembi. Another drug, Aduhelm, was approved in 2021 through the FDA’s accelerated pathway, but the manufacturer, Biogen, announced it would cease production and focus on developing a new drug. In trials of Leqembi, some patients also experienced brain hemorrhages, though at a lower rate than seen with donanemab.
Lilly's new drug was approved under the guidelines which postulate that that the treatment can be stopped if patients' MRI scans show improvement.
Approximately 120,000 Israelis suffer from dementia diseases, the most prominent being Alzheimer’s. This progressive degenerative disease gradually destroys brain cells, leading to cognitive decline, memory loss, and impairment of thinking, concentration, learning, and communication skills. Patients often also suffer from hyperactivity, hallucinations, and insomnia.
Most patients die within 10-15 years of disease onset. Currently, diagnosis relies on disease symptoms, with some hospitals recently adding to the diagnostic process a test for the presence of disease proteins in spinal fluid. Additionally, a new blood test has been approved, enabling early diagnosis of the disease, even years before the first symptoms appear.