The Food and Drug Administration has allowed Eli Lilly's new Alzheimer's drug, donanemab, advertised as Kisunla, which clinical trials signify can slightly slow the decrease in memory and cognitive capacities in Alzheimer's patients.
FDA Approves Eli Lilly's Alzheimer's Drug Kisunla
Kisunla is applied as a monoclonal antibody infusion every four weeks and is allowed for adults with mild cognitive deficiency or early Alzheimer's illness. It aims to amyloid plaques in the brain, an important sign of Alzheimer's.
Dr. Ronald Petersen, a neurologist at the Mayo Clinic, highlighted the approval's significance as it allows other medication choices for this incapacitating illness.
Formerly, the FDA fully authorized a similar drug, Leqembi, last summer. Petersen noted that it would give choices for both clinicians and patients.
According to the Alzheimer's Association, 6.7 million Americans aged 65 and older were living with Alzheimer's last year, with predictions recommending this number could increase to 13.8 million by 2060.
The FDA authorized Kisunla after a late-stage clinical trial with 1,700 participants displayed a 35% slower Alzheimer's advancement over 18 months compared to a placebo.
The trial used the clinical dementia rating scale to evaluate memory, orientation, judgment, problem-solving, community affairs, home and hobbies, and personal care.
These results were comparable to those observed with Leqembi. Eli Lilly anticipates that once patients' amyloid levels are significantly reduced, they may discontinue treatment.
However, it is uncertain if or when amyloid levels might return, necessitating a restart of the treatment.
Potential Side Effects of Kisunla
Similar to other medications in its category, Kisunla carries risks of serious side effects such as brain swelling and bleeding. The FDA noted that while most side effects in the trial were mild, three deaths were linked to the drug.
Kisunla is the second drug of its kind approved after Leqembi, following the withdrawal of Biogen's Aduhelm earlier this year.
Pat Bishara, aged 79 and from Carmel, Indiana, took part in both the phase 3 and extension trials of Kisunla following a diagnosis of mild cognitive impairment in late 2017.
She reported no significant side effects and credits the treatment with her stable condition. She expressed that she believes she wouldn't be as well as she is now if she hadn't been on medication.
Kisunla is priced at $32,000 annually, with Medicare anticipated to provide coverage for the treatment. Last year, the Centers for Medicare and Medicaid Services agreed to fund new FDA-approved Alzheimer's drugs, with the stipulation that physicians collect real-world performance data.
The FDA delayed its decision on Kisunla from March to consult its advisory panel on the balance of benefits and side effects. Last month, the panel commonly suggested the drug's authorization.
Safety Issues with FDA-Approved Anti-Amyloid Treatments
FDA-authorized anti-amyloid medications for Alzheimer's carry a boxed cautionary for "amyloid-related imaging abnormalities" seen on MRI scans, often without manifestations but possibly causing serious concerns like brain function problems and seizures.
In trials, about a quarter of participants receiving Eli Lilly's donanemab showed these abnormalities, with five deaths linked to brain hemorrhages among recipients.
The trials included older patients and those with the APOE ε4 gene, known to increase Alzheimer's risk and susceptibility to these abnormalities.
During the trials, about 10% of donanemab beneficiaries encountered infusion reactions, compared to 0.5% in the placebo group. Manifestations included chills, skin redness, nausea, shortness of breath, headache, and chest pain.
About 3% of those treated with donanemab progressed hypersensitivity reaction to the infusion, including 0.3% with an intense allergic reaction.
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