Yahoo Finance Eli Lilly (LLY) Gets FDA Nod for Alzheimer's Drug Donanemab
Eli Lilly and Company LLY announced that the FDA has granted approval to its drug donanemab for treating early symptomatic Alzheimer's disease (“AD”). The drug will be sold under the brand name Kisunla for treating early symptomatic AD in adults with mild cognitive impairment (MCI) as well as those with the mild dementia stage of AD, with confirmed amyloid pathology.
The approval was kind of expected after last month, when an FDA committee assessing the safety and effectiveness of donanemab voted 11-0, unanimously recommending its approval. The Peripheral and Central Nervous System Drugs Advisory Committee said that data from clinical studies on donanemab demonstrated substantial evidence of efficacy and a clinically meaningful slowdown in disease progression for early symptomatic Alzheimer’s patients. Overall, the committee voted that the benefits of donanemab outweighed the risks despite some safety concerns.
Kisunla will be the second drug on the market to treat AD. Biogen BIIB and its Japan-based partner Eisai’s Leqembi was approved by the FDA for early Alzheimer’s disease in the United States in July 2023. Leqembi is also approved in China and Japan. Regulatory applications seeking approval of Leqembi are under review in Europe.
Eli Lilly’s stock has risen 55.5% year to date compared with an increase of 21.1% for the industry.
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Kisunla’s BLA was based on data from the TRAILBLAZER-ALZ 2 phase III study. Data from the study showed that 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%. One monthly intravenous infusion of Kisunla reduced amyloid plaques on average by 84% at 18 months compared to the start of the study in the overall population of participants.
Alzheimer's disease is a devastating neurodegenerative disorder characterized by the accumulation of tau tangles and amyloid beta (Aβ) plaques in the brain. Donanemab is an Aβ targeting therapy. Aβ is a protein that is said to be the primary cause of the cognitive decline associated with Alzheimer’s disease.
According to Lilly, Kisunla is the only Aβ 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. The cost of treatment for 12 months was $32,000 while that for six months was $12,522. In comparison, Leqembiis infused once every two weeks for a minimum of 18 months with an annual cost of $26,500 annually.
However, anti-amyloid antibodies like donanemab can cause a brain swelling side effect called amyloid-related imaging abnormalities (ARIA). As expected, Kisunla’s label includes a black-box warning for ARIA, similar to Leqembi’s label.
The Centers for Medicare & Medicaid Services has also granted broad reimbursement to Aβ targeting therapies like Leqembi and Kisunla under Medicare plans.
Though the Leqembi launch is progressing slowly, Biogen believes it has the potential to generate blockbuster sales as there remains a massive unmet need for Alzheimer's disease. Biogen expects sales of Leqembi to start growing from 2024 with signs of acceleration seen in the first quarter.
Prothena Corporation PRTA, AC Immune and Cassava Sciences SAVA are also developing therapies for Alzheimer's disease. Prothena’s Alzheimer’s candidate is PRX012, also an Aβ targeting therapy, which is in early-stage development. Prothena is also developing a dual Aβ-tau vaccine, PRX123, a potential prevention and treatment for Alzheimer's disease.
Cassava Sciences is conducting a phase III program consisting of two global studies of simufilam in patients with mild-to-moderate Alzheimer’s disease dementia. Top-line data from the 52-week RETHINK-ALZ study is expected by the end of 2024, while that from the second study, the 76-week REFOCUS-ALZ study, is expected by mid-2025.
Eli Lilly currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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