The US Food and Drug Administration (FDA) gave a green light to a new Alzheimer's drug that slightly delays the disease's progression. The food and drug regulator approved Eli Lilly's Kisunla, which modestly slows the disease, offering fresh hope for individuals in the initial stages of this devastating, memory-robbing condition.
A woman, suffering from Alzheimer's desease, looks at an old picture on March 18, 2011 in a retirement house in Angervilliers, eastern France. (Photo : SEBASTIEN BOZON/AFP via Getty Images)
FDA Approves Eli Lilly's Kisunla Drug For Alzheimer's Disease
The FDA approved Eli Lilly's Kisunla on Tuesday for mild or early cases of dementia due to Alzheimer's. It is the second drug demonstrated to effectively postpone cognitive decline in patients following the previous year's clearance of a similar medication from Japanese pharmaceutical company Eisai.
The efficacy observed with both medications translates to several months, approximately seven months, specifically for Eli Lilly's drug. Patients and their families must carefully consider this benefit against the potential drawbacks, such as the necessity for regular intravenous infusions and the risk of serious side effects like cerebral edema.
The Associated Press reported that medical professionals specializing in Alzheimer's treatment emphasize the significance of this approval following numerous unsuccessful attempts at developing effective therapies over the decades.
Dr. Suzanne Schindler, a neurologist at Washington University in St. Louis, expressed her enthusiasm for having additional treatment options for her patients. She cited the difficulty she faces as a dementia specialist who sees the progression of Alzheimer's disease in her patients until they die.
Both Kisunla and Japanese drug Leqembi, developed in laboratories as antibodies, are administered intravenously and target a key factor in Alzheimer's disease: the accumulation of sticky amyloid plaques in the brain.
Uncertainty persists regarding which patients are suitable candidates for these medications and the duration of their potential benefits. The new drug's approval was anticipated following a unanimous recommendation from an external panel of FDA advisors during a public meeting last month.
Despite FDA reviewers' concerns about Eli Lilly's study methods, such as allowing patients to stop treatment once their amyloid plaque levels dropped significantly, the panel endorsed its benefits.
According to Eli Lilly, the drug's costs will depend on each patient's treatment duration. The company further noted that a full year of therapy would cost $32,000, which is more expensive than the $26,500 price tag for a year of Leqembi treatment.
The FDA's guidelines advise doctors to consider discontinuing the medication once brain scans confirm minimal plaque in patients. Over six million Americans are affected by Alzheimer's disease.
The new drug, Kisunla (donanemab), has been approved by the FDA primarily for individuals with early or mild forms of the disease. However, only a small portion of these patients are expected to complete the complex process required to obtain a prescription.
