Eli Lilly's Donanemab Approval Heats Up Alzheimer's Disease Treatment Market | DelveInsight

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Jul 08, 2024, 17:31 ET

In a much-anticipated decision, the FDA approved Eli Lilly's donanemab. This anti-amyloid antibody is the third drug intended to alter the progression of Alzheimer's disease treatment. This approval will intensify the competition between Eli Lilly's Donanemab and Biogen and Eisai's ADUHELM (aducanumab), and LEQEMBI (lecanemab).

LAS VEGAS , July 8, 2024 /PRNewswire/ -- Alzheimer's disease, the most common type of dementia, is a progressive neurodegenerative disorder with a multifactorial pathogenesis. It is characterized by a gradual decline in cognitive and functional abilities, with individuals eventually losing the ability to undertake everyday tasks and function independently.

As per DelveInsight analysis, in 2023, the total diagnosed prevalent cases of Alzheimer's disease in the 7MM were 15.4 million. These cases are projected to increase further during the forecast period (2024–2034).

In 2023, the United States had the highest proportion of diagnosed prevalent cases of Alzheimer's disease among the 7MM, comprising approximately 41% of the total cases. Conversely, the United Kingdom had the lowest share, representing nearly 4% of the total diagnosed prevalent cases of Alzheimer's in 2023.

As the size and proportion of the US population aged 65 and older continue to increase, the number of Americans with Alzheimer's or other dementias will grow.

While there is no cure for Alzheimer's disease at present, starting treatment early and maintaining it consistently is crucial for alleviating clinical symptoms. Early diagnosis is vital for applying symptomatic therapies, addressing behavioral issues, and implementing lifestyle changes that can reduce the risk of dementia and potentially slow disease progression.

Most current dementia treatments focus on increasing the levels of specific brain neurotransmitters like acetylcholine, serotonin, and noradrenaline, or decreasing the activity of others, such as glutamate and dopamine. Because of potential side effects, it's crucial to tailor dementia treatment to individual patients, taking into account their other health conditions and therapies. The impact on heart function, drug elimination, and other interactions should be evaluated individually. Medications like acetylcholinesterase inhibitors (AChEIs) and the N-methyl-D-aspartate (NMDA) receptor antagonist memantine have been available in the US for over ten years for symptomatic relief.

Approval of novel anti-amyloid biologics, which are 'disease-modifying,' with novel targeted mechanisms of action, has led to significant improvements from the traditional symptomatic treatment regime. With an improved pathological understanding of Alzheimer's and the discovery of new therapeutic targets, novel monoclonal antibodies have been approved in the last couple of years. In June 2021, Biogen and Eisai's ADUHELM (aducanumab) received accelerated approval, and in July 2023 LEQEMBI (lecanemab) received the full US FDA approval.

Learn more about the FDA-approved Alzheimer's disease drugs @ Drugs for Alzheimer's Disease Treatment

Biogen and Eisai's ADUHELM was granted accelerated approval by the FDA for treating early Alzheimer's disease, including mild cognitive impairment due to Alzheimer's. It is the first treatment to target amyloid β plaques and address Alzheimer's pathology. However, the drug is not widely available since it hasn't received traditional approval in the US and was rejected in Europe and Japan, tempering expectations for its success.

LEQEMBI (lecanemab), another drug by Biogen and Eisai, received accelerated approval from the US FDA in January 2023. By July 2023, this approval was upgraded to a traditional one following a confirmatory trial that demonstrated a 27% slowing in decline, confirming the drug's clinical benefits. This achievement is a significant milestone, addressing the unmet needs of patients with early Alzheimer's and paving the way for future biologics and drugs targeting the disease's underlying pathology. This approval is advantageous for Biogen and Eisai, ensuring their profitability, and first-mover market advantage, and helping them recover from the ADUHELM setback.

Moreover, after declining Eli Lilly's Alzheimer's drug donanemab for accelerated approval last year, the agency has now granted the anti-amyloid therapy full approval. This makes it a competitor to Eisai and Biogen's LEQEMBI.

The FDA has approved donanemab-abzt, branded as KISUNLA, for treating adults with early symptomatic Alzheimer's disease, which includes individuals with mild cognitive impairment and those in the early stages of dementia.

KISUNLA, administered monthly, stands as the pioneering treatment directed at amyloid plaques, backed by evidence allowing for cessation upon plaque removal. This approach aims to reduce treatment expenses and minimize infusion frequency.

To know more about Alzheimer's disease treatment options, visit @ New Treatment for Alzheimer's Disease

The Alzheimer's disease market is crowded with so many companies including BioVie, AB Science, Cassava Sciences, TauRx Therapeutics, Novo Nordisk, Eli Lilly, Athira Pharma, Alzheon, Eisai, and others are running clinical trials to improve the treatment space. The Alzheimer's disease pipeline possesses potential drugs in mid-stage developments to be launched shortly.

Some of the promising drugs in the pipeline include NE3107, masitinib (AB1010), simufilam (PTI-125), Hydromethylthionine mesylate (TRx0237), semaglutide (NN6535), remternetug, fosgonimeton (ATH-1017), ALZ-801 (valiltramiprosate), E2814, and others that hold the potential to create a significant positive shift in the Alzheimer's disease market size.

Discover which therapies are expected to grab major Alzheimer's disease market share @ Alzheimer's Disease Market Report

BioVie's NE3107 is an orally administered small molecule that can penetrate the blood-brain barrier. It acts as an anti-inflammatory and insulin sensitizer by binding to extracellular signal-regulated kinase (ERK), selectively inhibiting inflammation. NE3107 blocks the activation of ERK/NFkB and the production of TNF triggered by inflammatory stimuli like lipopolysaccharide. BioVie is developing NE3107 for the treatment of Parkinson's disease, multiple myeloma, and prostate cancer. Despite Phase III results not meeting the primary efficacy endpoint due to exclusions, the trial's adaptive design allows continued patient enrollment to achieve statistical significance for regulatory approval. Based on promising efficacy signals from the trial, BioVie plans to collaborate with the US FDA to achieve this goal, aiming for a global launch by 2026.

AB Science's Masitinib (AB1010) is an oral tyrosine kinase inhibitor designed to target activated cells of the neuro-immune system, specifically mast cells and microglia, which can accumulate within the central nervous system (CNS) at effective therapeutic levels. Research increasingly links mast cells and microglia to the pathophysiology of Alzheimer's disease. Evidence suggests that Masitinib may offer therapeutic benefits in treating patients with mild-to-moderate Alzheimer's disease, as demonstrated in a Phase II study. AB Science is currently conducting a Phase III trial to further confirm these findings.

Cassava Sciences' Simufilam (PTI-125) is a small-molecule drug candidate designed to bind and reverse an altered form of the scaffolding protein filamin A (FLNA), which plays a crucial role in regulating the actin cytoskeleton in the brains of Alzheimer's disease patients. Administered orally, simufilam enhances the function of multiple brain receptors and exhibits potent anti-neuroinflammatory effects. Cassava Sciences is currently conducting Phase III clinical trials to evaluate simufilam tablets for Alzheimer's disease, with enrollment completed for both studies. The company expects to release top-line data by the end of 2024 for the first study and by mid-2025 for the second study.

Discover more about drugs for Alzheimer's disease in development @ Alzheimer's Disease Clinical Trials

The anticipated launch of these emerging therapies for Alzheimer's disease are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the Alzheimer's disease market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.

DelveInsight estimates that the market size for Alzheimer's disease is expected to grow from USD 2.6 billion in 2023 with a significant CAGR by 2034. This growth can be attributed to the introduction of upcoming therapies and the rising prevalence of the disease. The anticipated launch of these therapies is also expected to attract new entrants to the Alzheimer's disease market, resulting in increased competition and innovation.

DelveInsight's latest published market report titled as Alzheimer's Disease Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the Alzheimer's disease country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The Alzheimer's disease market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:

Total Diagnosed Prevalent Cases of Alzheimer's Disease
Age-specific Cases of Alzheimer's Disease
Gender-specific Cases of Alzheimer's Disease
Severity-specific Cases of Alzheimer's Disease

The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM Alzheimer's disease market. Highlights include:

11-year Forecast
7MM Analysis
Epidemiology-based Market Forecasting
Historical and Forecasted Market Analysis upto 2034
Emerging Drug Market Uptake
Peak Sales Analysis
Key Cross Competition Analysis
Industry Expert's Opinion
Access and Reimbursement

Download this Alzheimer's disease market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the Alzheimer's disease market. Also, stay abreast of the mitigating factors to improve your market position in the Alzheimer's disease therapeutic space.

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