Kisunla is the only amyloid plaque-targeting medication that is administered once a month and has evidence to support terminating treatment when amyloid plaques are eliminated. This may lead to reduced treatment costs and fewer infusions.
The body naturally produces a protein called amyloid, which may clump together to form amyloid plaques. The brain’s overabundance of amyloid plaques may cause memory loss and cognitive problems linked to Alzheimer’s disease.
Those treated with Kisunla who were less advanced in their condition had a 35% decrease in deterioration compared with placebo on the integrated Alzheimer’s condition Rating Scale (DRS), which evaluates thinking, memory, and everyday functioning. This was shown in the TRAILBLAZER-ALZ 2 Phase 3 research.
Using the iADRS, the response to therapy for the whole group was likewise statistically significant at 22%.
Those receiving Kisunla had a 39% lower chance than those receiving a placebo of moving on to the next clinical stage of the illness, out of the two groups that were examined.
In comparison to the beginning of the trial, Kisunla decreased the average number of amyloid plaques in the whole participant population by 61% at six months, 80% at twelve months, and 84% at eighteen months.
Kisunla’s clearance comes after that of Eisai Ltd.’s ESLF and Biogen Inc.’s BIIB.
The second anti-beta-amyloid monoclonal antibody for Alzheimer’s disease to be authorized in as many years is ESAIY Leqembi.
Leqembi is priced at $26,500 a year, while Kisunla has a list price of $32,000, making it the more costly choice.
It does, however, have the option to discontinue treatment early if a PET scan identifies low levels of amyloid plaque, which may help to defray longer-term expenditures (in TRAILBLAZER-2, 47% of participants treated with donanemab quit therapy after 12 months).
According to William Blair
AdCom’s opinion and regulatory trust in anti-amyloid antibodies as a therapy for Alzheimer’s disease is reflected in Kisunla’s wide label.
This was a predictable result, according to the analyst, and it should hardly affect Biogen’s stock price.
With approximately 6 million Alzheimer’s patients in the United States, Kisunla and Leqembi have a substantial competitive advantage, but there is still room in the market for both.
After the Aduhelm debacle, a second approval will increase trust in the effectiveness of anti-amyloid antibodies.
Eisai projects $350 million in Leqembi sales between March 2024 and March 2025. The analyst will track adoption while pointing out the early benefits that Kisunla may provide.
Despite a slower start, William Blair continues to rate Biogen as an Outperform, seeing Leqembi to be a key growth driver.
According to Goldman Sachs, the clearance label is by expectations; it does not call for tau-based screening and contains cautions and monitoring criteria identical to those included for Leqembi.
Goldman Sachs updates the model with Eli Lilly’s price objective of $793 (up from $785 previously) to reflect the enhanced chance of program success to 100% in the U.S.
Biogen concentrates on the advancement of the launch concerning logistical and infrastructure impediments. According to a Goldman Sachs analyst, Kisunla’s arrival is a good step toward developing and growing the market for this generation of treatments for Alzheimer’s disease.
Price Action:
As of Wednesday’s latest check, shares of LLY were down 2.21% at $886.90, while shares of BIIB were down 2.43% at $223.27.
