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.
Related Reports
Alzheimer's Disease Epidemiology
Alzheimer's Disease Epidemiology Forecast –
2032 report delivers an in-depth understanding of the
disease, historical and forecasted Alzheimer's
disease epidemiology in the 7MM, i.e., the United States, EU4 (Germany, Spain, Italy,
and France), the United Kingdom, and Japan.
Alzheimer's Disease Pipeline
Alzheimer's Disease Pipeline Insight – 2024 report
provides comprehensive insights about the pipeline landscape,
pipeline drug profiles, including clinical and non-clinical stage
products, and the key Alzheimer's Disease companies,
including Biogen, AZTherapies, Cerecin, Neurotrope,
Synaptogenix, INmune Bio, Cassava Sciences, EIP Pharma, Neuraly, AB
Science, Cortexyme, Anavex Life Sciences, Athira Pharma, Time
Therapeutics, Denali Therapeutics Inc., Alector Inc., Lexeo
Therapeutics, TrueBinding, Inc., Vaccinex Inc., Annovis Bio Inc.,
Eisai Inc., Hoffmann-La Roche, Ionis Pharmaceuticals, Inc., Otsuka
Pharmaceutical Co., Ltd., Cognition Therapeutics, Merck Sharp
& Dohme LLC, ImmunoBrain Checkpoint, AbbVie, AriBio Co.,
Ltd., Oryzon Genomics S.A., Eli Lilly and Company, Neurokine
Therapeutics, Excelsior, Seelos Therapeutics, Inc., Janssen
Research & Development, LLC, Shanghai Hengrui Pharmaceutical
Co., Ltd., reMYND, Alzinova AB, VTBIO Co. LTD, BioVie Inc.,
Prothena Corporation plc, Coya Therapeutics, Inc., among
others.
Parkinson's Disease Pipeline
Parkinson's Disease Pipeline Insight – 2024 report
provides comprehensive insights about the pipeline landscape,
pipeline drug profiles, including clinical and non-clinical stage
products, and the key Parkinson's disease companies,
including Cerevel Therapeutics, Inhibikase Therapeutics,
Neuraly, Peptron, Biogen, Roche, Brain Neurotherapy Bio, Inc.,
Modag, Annovis Bio Inc., BioVie Inc., United Neuroscience Ltd.,
Luye Pharma Group, AbbVie, UCB Biopharma SRL, InnoMedica Schweiz
AG, Integrative Research Laboratories AB, H. Lundbeck A/S, Shanghai
WD Pharmaceutical Co., Ltd., Cerevance Beta, Inc., Nobilis
Therapeutics Inc., BlueRock Therapeutics, Taiwan Mitochondrion
Applied Technology Co., Ltd., among others.
Psychosis in Parkinson's and Alzheimer's Disease
Market
Psychosis in Parkinson's and Alzheimer's Disease Market
Insights, Epidemiology, and Market Forecast – 2032 report
delivers an in-depth understanding of the disease, historical and
forecasted epidemiology, as well as the market trends, market
drivers, market barriers, and key psychosis in Parkinson's and
Alzheimer's disease companies, including Sunovion
Pharmaceuticals, Karuna Therapeutics, Vanda Pharmaceuticals, Suven
Life Sciences, Enterin, Intra-Cellular Therapies, Merck Sharp &
Dohme, among others.
About DelveInsight
DelveInsight is a leading Business Consultant and Market
Research firm focused exclusively on life sciences. It supports
pharma companies by providing comprehensive end-to-end solutions to
improve their performance. Get hassle-free access to all the
healthcare and pharma market research reports through our
subscription-based platform PharmDelve.
Contact Us
Shruti
Thakur
info@delveinsight.com
+14699457679
Logo:
https://mma.prnewswire.com/media/1082265/3528414/DelveInsight_Logo.jpg
View original
content:https://www.prnewswire.co.uk/news-releases/eli-lillys-donanemab-approval-heats-up-alzheimers-disease-treatment-market--delveinsight-302190544.html