22 Aug FDA Approves Another Drug That Slows Cognitive Decline
In July 2024, the FDA approved Kisunla (formerly called Donanemab) which is anti-amyloid clearing treatment which slows cognitive decline by 35% (up to 60% in a separate analysis). Although the FDA rejected Eli Lilly’s request for accelerated approval of the drug in January 2023 since there was an insufficient number of study participants who had received at least 12 months of the treatment, full approval was received 18 months later.
Leqembi was the first drug to reduce amyloid beta plaques in the brain. There is a connection between the amyloid beta plaques and memory loss due to the sticky substance’s damage to the brain cells. Kisunla’s testing shows more likelihood of success than Leqembi. Approximately 47% of participants taking Kisunla in the early stages after a diagnosis showed no clinical progression of the disease.
The drug is given by infusion. Prior to being eligible for this drug, a certain type of brain scan or a spinal tap must confirm amyloid plaque in the brain for those with mild dementia. Side effects could include the possibility of brain swelling and bleeding (as does Leqembi) although most did not have these symptoms. Only 2% have serious side effects.
Those on Medicare may receive coverage and reimbursement. The cost for others depends on length of treatment and insurance coverage. The list price is $32,000 per year (vs Leqembi at $24,000 per year).
One major advantage of Kisunla is that patients can stop the drug after it clears the amyloid protein. This reduces the costs, inconvenience of the treatment and reduces the risk of side effects. Lilly’s study showed 69% of those in the clinical trial were able to stop treatment within 18 months.
Additionally it was announced on August 1, 2024 at the Alzheimer’s Association International Conference (AAIC) that:
1) GLP-1, a drug that helps those with diabetes and weight loss, appears to protect the brain and slow cognitive decline;
2) Blood tests may revolutionize accuracy of Alzheimer’s Disease diagnosis resulting speedier access to approved treatment; and
3) Breathing wildfire smoke and eating too much processed red meat may raise the risk of cognitive decline.
Although neither Kisunla nor the announcements at the AAIC are a cure, these are steps forward in the fight against Alzheimer’s. Other types of drugs (such as fighting the tau protein and neuroinflammation) are presently in clinical trials as we continue to advance in finding a cure. If you would like to join our Walk Team, in Michael’s Marchers, to benefit the Alzheimer’s Association, click here. The Dallas Walk is on November 2, 2024.