In a significant development for Alzheimer’s patients and their families, Eli Lilly & Co.’s new treatment Kisunla has recently been approved in the US. This marks the second drug designed to slow the progression of this debilitating disease, which currently affects around 6 million Americans.
Kisunla’s journey to approval has been far from straightforward, with several regulatory obstacles to overcome. Nevertheless, the drug’s potential was recognised early on, with promising results from clinical trials more than three years ago. Now, it is set to compete with Leqembi, an Alzheimer’s drug developed by Eisai Co. that has been available in the US since early 2023.
From a financial perspective, the first year of treatment with Kisunla is priced at $32,000. While this is slightly higher than Leqembi’s annual cost of $26,500, Kisunla offers potential savings down the line. If brain plaques – the toxic substances the drug targets – fall to minimal levels, which happened in many trial participants after a year, doctors can discontinue the treatment.
Lower Costs with Kisunla
According to Eli Lilly, this could make Kisunla’s total treatment cost lower than other amyloid drugs in some cases. Both Kisunla and Leqembi are administered via infusions that remove toxic amyloid from the brains of Alzheimer’s patients. However, these treatments only modestly slow the progression of the disease and are only approved for use in early-stage Alzheimer’s patients.
It’s worth noting that these drugs can cause side effects, including brain swelling and bleeding. In fact, around 36% of patients on Lilly’s drug experienced these effects in the company’s main study. Therefore, regular scans are required to monitor for these potential complications. However, compared to Leqembi, which is administered every two weeks, Kisunla offers a more convenient dosing schedule, with infusions required every four weeks.
Delays in Kisunla’s Journey to Approval
Kisunla’s approval process was not without its challenges. The FDA initially refused to grant the drug accelerated approval, opting to wait for results from a late-stage trial. Once this data was submitted, the FDA required additional time for review. A day-long hearing was even held earlier this year to review Kisunla’s safety and efficacy.
Despite these hurdles, a panel of outside advisers to the FDA voted unanimously in favor of Kisunla on June 10. As Anne White, president of Lilly Neuroscience, expressed, the approval brought a wave of emotion to the team at Lilly.
While Alzheimer’s treatments are a key part of Lilly’s future plans, the company’s GLP-1 medicines for weight loss have recently taken center stage. Analysts at Goldman Sachs predict that this market could potentially reach $130 billion a year by the end of this decade. Nonetheless, Alzheimer’s drug sales are also expected to see significant growth, with Bloomberg Intelligence analysts predicting a surge to $13 billion by 2030, up from around $250 million this year.
Joanne Pike, CEO of the Alzheimer’s Association, welcomed the approval of Kisunla, stating: “Having multiple treatment options is the kind of advancement we’ve all been waiting for.” Despite the challenges and uncertainties surrounding the rollout of these treatments, their approval and increased coverage by insurance companies mark a significant step forward in the fight against Alzheimer’s.
