FDA Greenlights Second Drug to Slow Alzheimer’s Disease Progression
In a move that provides fresh hope to patients, the US Food and Drug Administration has approved a second drug for mild Alzheimer’s disease that has been shown to moderately delay cognitive decline. The drug, called Kisunla and developed by pharmaceutical giant Lilly, follows in the footsteps of Eisai’s earlier Alzheimer’s treatment Leqembi which was permitted last year.
Both drugs work by targeting amyloid plaques, sticky protein deposits in the brain that are considered a hallmark of Alzheimer’s pathology. In an 18-month clinical study, Kisunla reduced cognitive and memory worsening by around 22% compared to a placebo. This modest benefit translates to a delay of approximately seven months in symptoms worsening.
Safety will be an important consideration for patients as these plaque-removing drugs can potentially cause brain swelling or bleeding in some cases. Rates were a bit higher with Kisunla compared to Leqembi based on trial results, though the patient populations differed slightly. An advantage is that Kisunla only requires monthly IV infusions versus Leqembi’s twice monthly schedule. Additionally, if a person’s plaques are reduced significantly, they may be able to discontinue treatment as per trial protocols.
Only individuals in the early or mild stages of Alzheimer’s will qualify for these new options. Widespread access may be limited initially due to logistical hurdles like prescribing requirements, coverage, and infusion center availability. However, the approval of Kisunla together with Leqembi gives more treatment-seeking patients and their families hope for a future with fewer symptoms for as long as possible. The war against Alzheimer’s continues with these two new ammunition in the physician’s arsenal.