Breakthrough Clinical Results
AEON Biopharma announced that the FDA has scheduled a Biosimilar Biological Product Development (BPD) Type 2a meeting for ABP-450 (prabotulinumtoxinA) on November 19, 2025. The meeting will focus on AEON’s analytical development plan under the 351(k) biosimilar pathway, including its framework for assessing key quality attributes and its initial similarity data. The objective is to establish alignment with FDA on the scope and approach of the remainder of AEON’s analytical analysis, a foundational step in advancing ABP-450’s biosimilar development to BOTOX.
Key Highlights
- FDA schedules BPD Type 2a meeting for ABP-450 on November 19, 2025.
- Meeting to focus on AEON’s analytical development plan for ABP-450 as a BOTOX biosimilar.
- Objective is to establish alignment with FDA on the scope and approach of analytical analysis.
- AEON expects to provide an update on the outcome of the meeting following its completion and receipt of official FDA minutes.
Incidence and Prevalence
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Global Estimates of Debilitating Medical Conditions
Neurological Disorders
In China alone, 468.29 million prevalent cases of neurological disorders were reported in 2021, accounting for 78.10 million DALYs. Intracerebral hemorrhage leads the DALY burden, followed by ischemic stroke, dementias, and migraine. The burden peaks at ages 70-74 years and affects males more than females. From 1990-2021, DALYs decreased for idiopathic epilepsy and subarachnoid hemorrhage but increased for dementias, Parkinson's disease, and ischemic stroke.
Parkinson's disease is the fastest-growing neurological disorder, expected to affect over 12 million people globally by 2040. Its prevalence among individuals over 60 and 80 years ranges between 1% and 4%. Multiple sclerosis impacts approximately 2.8 million people globally.
Metabolic Disorders
Metabolic-associated fatty liver disease (MAFLD) affected an estimated 1.3 billion people worldwide in 2021. The global crude prevalence rate increased from 10.6% to 16.1% between 1990 and 2021, with age-standardized prevalence rising from 12.1% to 15.0%. The fastest increases occurred in countries with high-middle and middle SDI.
For high fasting plasma glucose (HFPG)-attributable metabolic dysfunction-associated steatotic liver disease (MASLD), 2021 saw 213.48 thousand DALYs and 10.02 thousand deaths globally, representing increases of 2.96 and 3.32 times since 1990.
Musculoskeletal Disorders
Musculoskeletal disorders (MSDs) showed a prevalence of 89.90% among older adults in a Thai clinic, with higher rates in females. The most affected body regions were the lower back, shoulders, and knees. Manual labor and heavy industry workers showed increased risk.
Mental Health Conditions
Anxiety disorders in Latin America showed prevalence rates of 14.55% (lifetime), 6.61% (12-month), and 3.27% (current). Higher prevalence was associated with greater income inequality and gender inequality.
Among India's tribal population, depression prevalence ranges from 3% to 43%, with a pooled prevalence of 14%. Anxiety disorders in this population show a pooled prevalence of 3%.
In a study of diabetes patients, 39.2% had a mental disorder. Among COVID-19 recovered patients in Iraq, 31.6% met criteria for post-traumatic stress disorder (PTSD) and 21.05% were classified with probable depression.
Immune-Mediated Inflammatory Diseases
From 1990 to 2021, global age-standardized DALY rates increased for psoriasis (EAPC = 0.23%) and rheumatoid arthritis (EAPC = 0.05%), while declining for asthma (EAPC = -1.91%), atopic dermatitis (EAPC = -0.26%), inflammatory bowel disease (EAPC = -0.52%), and multiple sclerosis (EAPC = -0.39%).
Other Conditions
Chronic rhinosinusitis (CRS) showed a global pooled prevalence of 8.71%, with higher rates in Europe compared to other regions. Prevalence increased from 4.72% (1980-2000) to 19.40% (2014-2020).
Colorectal cancer global incidence cases increased by 157.23% from 1990 to 2019, with the highest increases in Equatorial Guinea, Vietnam, and China.
Dementia incidence in Germany declined by 26% from 2015 to 2022, with prevalence falling by 18% during the same period.
Emerging Mechanism of Action
Emerging Mechanisms of Action for Debilitating Medical Conditions
Recent publications highlight several novel mechanisms of action for treating debilitating conditions:
Multiple Sclerosis Treatments
Fingolimod, a sphingosine-1-phosphate-receptor modulator, has shown significant efficacy with improved relapse-free rates (86.3% vs. 32.6%), decreased MRI activity (18.3% vs. 77.7%), and improved EDSS scores. Most disease-modifying drugs (DMDs) work through chronic immune suppression, though access remains limited with less than 35% of Latin American patients receiving treatment.
Rheumatoid Arthritis Therapies
Treatment strategies have evolved with methotrexate (MTX) as the predominant initial DMARD, followed by biological DMARDs (bDMARDs) and targeted synthetic DMARDs (tsDMARDs). JAK inhibitors like tofacitinib and baricitinib target the Janus kinases family (JAK1, JAK2, JAK3). Marine biomolecules including Sargachromanol G and Isopseudopterosin E show promising JAK1 binding. Catalpol (CAT), an iridoid glycoside, effectively reduces arthritis inflammation in preclinical models.
Autoimmune Condition Treatments
Current therapies include B cell-depleting agents (Rituximab), T cell-targeting agents (Abatacept), and cytokine inhibitors targeting IL-17 or IL-23. For hidradenitis suppurativa, approved biologics include anti-TNF-α antibody adalimumab, anti-IL-17A secukinumab, and anti-IL-17A/17F bimekizumab. Drugs targeting the IL-17 and JAK/STAT pathways show promise in phase 3 studies.
Hypereosinophilia Treatments
While corticosteroids remain first-line treatment, imatinib shows high efficacy particularly in patients with FIP1L1::PDGFRA fusion. Biologic therapies targeting interleukin (IL)-5 or its receptor, such as mepolizumab and benralizumab, demonstrate promise in reducing eosinophil counts and preventing flare-ups. Dupilumab and lirentelimab are under investigation.
Neurodegenerative Disease Approaches
Research indicates disease markers in Alzheimer's and Parkinson's form part of a pathological network involving multiple cell types, particularly astrocytes. Multitarget approaches are emerging, including compounds targeting both tau and amyloid β, multitarget inhibitors for monoamine oxidase (MAO) and cholinesterase (ChE), and dual inhibitors of acetylcholinesterase (AChE) and beta-site amyloid precursor protein cleaving enzyme 1 (BACE-1). Mitophagy enhancers like Urolithin A show promise in reversing mitochondrial deficits.
Psychedelic-Assisted Therapy
Psychedelic-assisted therapy (PAT) is emerging with MDMA and psilocybin approved in Australia for mental health indications, while MDMA treatment is being explored for war-related PTSD in Ukraine.
Novel Metabolic Regulators
Tirzepatide, a novel GIP and GLP1 agonist, shows promise despite specific adverse events including gastrointestinal disorders and administration site conditions.
These emerging mechanisms represent significant advances in addressing complex debilitating conditions through targeted, multifaceted approaches.
Recent Studies
Recent Studies for Debilitating Medical Conditions
Deep Brain Stimulation (DBS) for Parkinson's Disease
A world-wide expert panel study using the RAND/UCLA Appropriateness Method assessed DBS referral appropriateness for Parkinson's disease. Positive associations for DBS referral included severity of on-off fluctuations, dyskinesias and refractory tremor (p < 0.001), while negative associations included cognitive impairment (p < 0.001) and levodopa-unresponsive gait and balance disturbances. The age cut-off was raised from 70 to 75 years compared to a 2005 study, reflecting evidence supporting DBS use in earlier stages of PD.
Adaptive Deep Brain Stimulation (aDBS)
A survey of 21 leading DBS experts worldwide using a 5-point Likert scale questionnaire and Delphi method found that adaptive DBS (aDBS), which provides dynamic symptom-related stimulation, is expected to become clinical routine in the next 10 years. Research is needed to define which patients would benefit more from the treatment, and implantation and programming procedures should be simplified.
Extracorporeal Shockwave Therapy (ESWT) for Peyronie's Disease
A meta-analysis of four RCTs with 301 patients found ESWT to be a safe short-term treatment with no significant difference in complication rates between groups. For efficacy outcomes, ESWT significantly reduced plaque size (OR 2.59, P=0.02) and significantly relieved pain (MD -1.55, P=0.0008), but had no significant effect on reducing penile curvature or improving sexual function.
PROMESS-Stress Program for Medical Students
This 3-session stress management program at Lyon-Est Faculty of Medicine includes individual meetings between experts and medical students to establish personalized advice and goals. The primary outcome is changes in scores on the Perceived Stress Scale (PSS), with secondary outcomes including effects on stress coping behaviors and psychological and physiological stress variables.
Cupping Therapy for Knee Osteoarthritis
A case study of a 57-year-old female patient showed significant improvements after 4 weeks (10 sessions): Numerical Pain Rating Scale score decreased from 8 to 2, WOMAC score improved from 50 to 25, and quality of life score measured by SF-36 improved from 35 to 75.
CAR T-cell Therapy for Autoimmune Diseases
CD19-directed chimeric antigen receptor (CAR) T-cell therapy has shown effectiveness in conditions such as SLE (systemic lupus erythematosus), systemic sclerosis, and myositis. Two case series suggest that drug-free remission can be sustained in patients with previously treatment-refractory disease, with the majority of remissions remaining durable up to 1-2 years from treatment.