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Eli Lilly Secures Approval for Alzheimer's Drug Kisunla in Japan
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Eli Lilly (LLY - Free Report) announced that its Alzheimer's disease (AD) drug Kisunla (donanemab) has been approved for use in Japan. The drug will treat early symptomatic AD in adults with mild cognitive impairment (MCI) and those with the mild dementia stage of AD, with confirmed amyloid pathology.
Japan is the second major market in which Kisunla has been approved for use. LLY received its first approval for the drug in the United States this July.
Both these approvals are based on data from the TRAILBLAZER-ALZ 2 phase III study, which showed that treatment with Kisunla slowed cognitive and functional decline by up to 35% in patients with less advanced disease compared to placebo at 18 months. It also showed that Kisunla reduced participants' risk of progressing to the next clinical stage of disease by up to 39%. A monthly intravenous infusion of Kisunla reduced amyloid plaques on average by 84% at 18 months compared with the start of the study in the overall population of participants.
This latest approval makes Lilly’s Kisunla the second drug to be approved in Japan that directly targets a specific cause of the disease — amyloid plaques. The first drug Leqembi, which is marketed by Biogen (BIIB - Free Report) and Japan-partnered Eisai, was approved for use last year. The Biogen-Eisai drug was also approved for use by the FDA last year.
LLY Stock Performance
Year to date, Eli Lilly’s shares have surged 58.6% compared with the industry’s 22.4% rise.
Image Source: Zacks Investment Research
Why the Japan Approval for LLY’s Kisunla Matters
Lilly considers Japan to be a major market for Kisunla. Management estimates that the number of dementia patients in Japan is expected to be more than five million by 2030. The most common form of dementia, AD, accounts for more than 67% of dementia cases in Japan. Lilly believes that this number is expected to rise significantly due to the country's rapidly aging population.
Does LLY’s Kisunla Have Any Competitive Advantage Over Leqembi?
Per Lilly, Kisunla is the only amyloid-targeting therapy that can be discontinued when amyloid plaques clear up, as shown by a PET scan. This will lower treatment costs and burden for patients. In the TRAILBLAZER-ALZ 2 phase III study, around 47% of participants completed treatment at 12 months and 17% completed treatment at six months.
Treatment with the Lilly drug requires the intravenous (IV) administration of a single dose once every four weeks compared with Biogen/Eisai’s Leqembi, which requires IV dosing once every two weeks.
AD is a devastating neurodegenerative disorder characterized by the accumulation of tau tangles and amyloid beta (Aβ) plaques in the brain. Aβ is a protein that is said to be the primary cause of the cognitive decline associated with this disease.
Other Players in the AD Space
The AD target market is highly competitive as several other pharma companies like Cassava Sciences (SAVA - Free Report) and Prothena (PRTA - Free Report) are developing their antibody candidates targeting the AD indication.
Cassava Sciences is conducting a phase III program consisting of two global studies on its orally-administered drug simufilam in patients with mild-to-moderate AD dementia. While SAVA expects top-line data from the 52-week RETHINK-ALZ study before 2024-end, it expects to report data from the 76-week REFOCUS-ALZ study by mid-2025.
Prothena is evaluating multiple AD candidates in early-stage studies targeting AD indication. PRTA is evaluating AD drug PRX012, also an amyloid-targeting therapy, in an early-stage study. Prothena is also developing a dual Aβ-tau vaccine, PRX123, a potential prevention and treatment for AD.
Image: Bigstock
Eli Lilly Secures Approval for Alzheimer's Drug Kisunla in Japan
Eli Lilly (LLY - Free Report) announced that its Alzheimer's disease (AD) drug Kisunla (donanemab) has been approved for use in Japan. The drug will treat early symptomatic AD in adults with mild cognitive impairment (MCI) and those with the mild dementia stage of AD, with confirmed amyloid pathology.
Japan is the second major market in which Kisunla has been approved for use. LLY received its first approval for the drug in the United States this July.
Both these approvals are based on data from the TRAILBLAZER-ALZ 2 phase III study, which showed that treatment with Kisunla slowed cognitive and functional decline by up to 35% in patients with less advanced disease compared to placebo at 18 months. It also showed that Kisunla reduced participants' risk of progressing to the next clinical stage of disease by up to 39%. A monthly intravenous infusion of Kisunla reduced amyloid plaques on average by 84% at 18 months compared with the start of the study in the overall population of participants.
This latest approval makes Lilly’s Kisunla the second drug to be approved in Japan that directly targets a specific cause of the disease — amyloid plaques. The first drug Leqembi, which is marketed by Biogen (BIIB - Free Report) and Japan-partnered Eisai, was approved for use last year. The Biogen-Eisai drug was also approved for use by the FDA last year.
LLY Stock Performance
Year to date, Eli Lilly’s shares have surged 58.6% compared with the industry’s 22.4% rise.
Image Source: Zacks Investment Research
Why the Japan Approval for LLY’s Kisunla Matters
Lilly considers Japan to be a major market for Kisunla. Management estimates that the number of dementia patients in Japan is expected to be more than five million by 2030. The most common form of dementia, AD, accounts for more than 67% of dementia cases in Japan. Lilly believes that this number is expected to rise significantly due to the country's rapidly aging population.
Does LLY’s Kisunla Have Any Competitive Advantage Over Leqembi?
Per Lilly, Kisunla is the only amyloid-targeting therapy that can be discontinued when amyloid plaques clear up, as shown by a PET scan. This will lower treatment costs and burden for patients. In the TRAILBLAZER-ALZ 2 phase III study, around 47% of participants completed treatment at 12 months and 17% completed treatment at six months.
Treatment with the Lilly drug requires the intravenous (IV) administration of a single dose once every four weeks compared with Biogen/Eisai’s Leqembi, which requires IV dosing once every two weeks.
AD is a devastating neurodegenerative disorder characterized by the accumulation of tau tangles and amyloid beta (Aβ) plaques in the brain. Aβ is a protein that is said to be the primary cause of the cognitive decline associated with this disease.
Other Players in the AD Space
The AD target market is highly competitive as several other pharma companies like Cassava Sciences (SAVA - Free Report) and Prothena (PRTA - Free Report) are developing their antibody candidates targeting the AD indication.
Cassava Sciences is conducting a phase III program consisting of two global studies on its orally-administered drug simufilam in patients with mild-to-moderate AD dementia. While SAVA expects top-line data from the 52-week RETHINK-ALZ study before 2024-end, it expects to report data from the 76-week REFOCUS-ALZ study by mid-2025.
Prothena is evaluating multiple AD candidates in early-stage studies targeting AD indication. PRTA is evaluating AD drug PRX012, also an amyloid-targeting therapy, in an early-stage study. Prothena is also developing a dual Aβ-tau vaccine, PRX123, a potential prevention and treatment for AD.
Eli Lilly and Company Price
Eli Lilly and Company price | Eli Lilly and Company Quote
LLY Zacks Rank
Eli Lilly currently carries a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.