A Phase I/II Study of Natalizumab as a Single Agent in Children, Adolescents and Young Adults With Recurrent, Refractory or Progressive Pulmonary Metastatic Osteosarcoma

The purpose of this study is to evaluate the safety and tolerability of Natalizumab in children, adolescent and young adult patients with pulmonary metastatic osteosarcoma (pOS) and to assess clinical response associated with this treatment as well as overall survival.

Start Date01 Dec 2024

Sponsor / Collaborator

The Case Comprehensive Cancer Center

NCT05658497

/ RecruitingNot Applicable

Vumerity (Diroximel Fumarate) Prospective MS Pregnancy Exposure Registry

The primary objectives of the study are to estimate the risk of major congenital malformations (MCMs) in infants born to women with multiple sclerosis (MS) who were exposed to diroximel fumarate (DRF) at any time from 2 weeks after the first day of their last menstrual period (LMP) up through the first trimester of pregnancy and to comparatively evaluate pregnancy outcomes with MCMs in women with MS who were exposed to DRF at any time from 2 weeks after the first day of their LMP through the first trimester of pregnancy with the following: i) women with MS who were unexposed to disease modifying therapies (DMTs) and, ii) women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries).
The secondary objective of the study is to evaluate pregnancy outcomes in women with DRF exposure at any time from 2 weeks after the first day of their LMP through the end of pregnancy compared with the following: i) women with MS who were unexposed to DMTs, ii) women with dimethyl fumarate (DMF) exposure, iii) women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries), and iv) women without MS (e.g., women from external, general population comparators).

Start Date27 Oct 2023

Sponsor / Collaborator

Biogen, Inc.

NCT05618301

/ Active, not recruitingPhase 1IIT

A Pilot Safety and Feasibility Study to Evaluate Motixafortide (CXCR4/SDF-1 Inhibition) and Natalizumab (VLA-4/VCAM-1 Inhibition) as a Novel Regimen to Mobilize CD34+ Hematopoietic Stem Cells for Gene Therapies in Sickle Cell Disease (SCD)

Hematopoietic stem cell (HSC)-based gene therapies now offer curative potential for patients with sickle cell disease (SCD), with decreased toxicity compared to allogeneic hematopoietic cell transplantation. However, effective HSC-based gene therapy depends on collecting sufficient HSCs to generate the therapeutic product, and currently available mobilization regimens carry unacceptable risk for patients with SCD or do not reliably yield optimal numbers of HSCs for gene therapy.
The investigators hypothesize that HSC mobilization with motixafortide (CXCR4i) alone and the combination of motixafortide plus natalizumab (VLA-4i) will be safe and tolerable in SCD patients. In addition, the investigators hypothesize that combined CXCR4 and VLA-4 blockade with motixafortide plus natalizumab will result in a rapid, robust, and synergistic increase in HSC mobilization to peripheral blood (PB) in patients with SCD, when compared to motixafortide alone.

Start Date07 Jul 2023

Sponsor / Collaborator

Washington University School of Medicine

[+2]

100 Clinical Results associated with Natalizumab

100 Translational Medicine associated with Natalizumab

100 Patents (Medical) associated with Natalizumab

3,068

Literatures (Medical) associated with Natalizumab

07 Apr 2025·Current Neuropharmacology

Comparing STRATIFY JCV™ DxSelect™ and IMMUNOWELL™ JCV IgG Tests in RRMS to Assess PML Risk

Article

Author: Marinelli, Fabiana ; Zanghì, Aurora ; Avolio, Carlo ; Filippo, Paola Sofia Di ; D’Amico, Emanuele

Background::

The risk of developing progressive multifocal leukoencephalopathy (PML), a rare but potentially fatal opportunistic infection of the Central Nervous System caused by the J.C. virus (JCV), remains a primary concern associated with natalizumab therapy in the clinical management of patients diagnosed with multiple sclerosis (MS).

Materials and Methods::

This study compared two tests, STRATIFY JCV™ DxSelect™, and IMMUNOWELL ™ JCV IgG, for assessing the risk of PML in patients diagnosed with relapsingremitting multiple sclerosis (RRMS) who had received disease-modifying therapy (DMT) with branded natalizumab (Tysabri®). The main objective was to determine the comparability of these tests in classifying PML risk. Eligible patients were selected from a database, and all specimens for the STRATIFY JCV™ DxSelect™ and IMMUNOWELL™ JCV IgG tests were collected on the same day. Patients were classified into three risk categories (low, intermediate, or high) based on threshold values for each test.

Results::

The analysis showed 85.5% agreement between the two tests for risk classification. Ten discordant cases were identified, mainly between intermediate- and high-risk categories. Compared to STRATIFY JCV™ DxSelect™, IMMUNOWELL™ tended to categorize more patients as higher risk. No significant association was found between discordance and prior use of immunosuppressant drugs and >24 doses of natalizumab. The agreement between tests, assessed with the weighted Kappa coefficient, was moderate (κ=0.6222).

Conclusions::

Compared to the STRATIFY JCV™ DxSelect™, the IMMUNOWELL™ JCV test tends to place more patients in higher risk categories. Further, longitudinal studies are needed to evaluate the clinical impact of these differences in PML risk assessment.

01 Apr 2025·NEUROLOGICAL SCIENCES

Effects of natalizumab on oligoclonal bands in the cerebrospinal fluid of patients with multiple sclerosis: a systematic review and meta-analysis

Review

Author: Zis, Panagiotis ; Tseriotis, Vasilis-Spyridon ; Liampas, Andreas ; Pourzitaki, Chryssa ; Bargiotas, Panagiotis ; Vavougios, George D ; Artemiadis, Artemios ; Mavridis, Theodoros ; Hadjigeorgiou, Georgios M

INTRODUCTION:

Oligoclonal bands (OCBs) in cerebrospinal fluid (CSF) are utilized for diagnosing multiple sclerosis (MS), as they are found in 95% of patients. Additionally, OCBs are linked to disease prognosis. The primary contributors to OCB production are long-lived plasma cells. This study aims to quantify the impact of natalizumab (NTZ) on OCB levels in the CSF of MS patients.

METHODS:

A systematic search on MEDLINE, SCOPUS and Web of Science for English-written and peer-reviewed longitudinal studies on adults was performed. Methodological quality was assessed with the Newcastle-Ottawa Scale. Proportional meta-analysis was performed in R using a generalized linear mixed-effects model. We investigated heterogeneity with influence diagnostics, sensitivity analysis and meta-regression.

RESULTS:

Eight eligible studies of adequate quality with a total sample of 326 relapsing-remitting MS patients were included. A summary rate of 14.07% [95% CI, 4.48%-36.36%] for complete loss of OCBs and 42.02% [95% CI, 15.23%-74.51%] for reduction in OCB number or intensity was observed, both with considerable heterogeneity. Pooled estimates dropped (11% [95% CI, 0.04%-0.29%] and 34% [95% CI, 0.11%-0.68%] respectively) after the identification of an influential study. Multivariable meta-regression identified IgG index as a factor contributing to heterogeneity (adj. p = 0.0279), regarding reduction of OCB number or intensity.

DISCUSSION:

In conclusion, our systematic review and meta-analysis showed that NTZ can lead to reduction of intrathecal OCBs in MS patients, indicating a possible effect of NTZ on memory plasma cells, which are the main source of OCBs in MS.

01 Apr 2025·NEUROLOGICAL SCIENCES

Anti-JCV antibody index seroconversion in Turkish multiple sclerosis patients treated with natalizumab

Article

Author: Gündüz, Tuncay ; Kürtüncü, Murat ; Emekli, Ahmed Serkan ; Şahin, Edanur ; Erden, Sevda Öztürk ; Ercanoğlu, Mazlum

BACKGROUND:

The anti-JCV antibody index is widely used to monitor multiple sclerosis (MS) patients receiving natalizumab, as seroconversion is linked to an increased risk of progressive multifocal leukoencephalopathy. This study aimed to evaluate the prevalence and risk factors of anti-JCV antibody seroconversion in patients treated with natalizumab.

METHODS:

We included MS patients exposed to natalizumab treatment for at least one year, with a negative anti-JCV antibody index at baseline, and a minimum of two anti-JCV antibody assessments more than six months apart. We employed Kaplan-Meier survival analysis to assess the median time to seroconversion and the annual seroconversion rate, and univariate and multivariate Cox regression models to evaluate the covariates.

RESULTS:

Among 96 patients followed for a median of 99 months, 29 (30.2%) patients had seroconversion. The median time to seroconversion was 8.3 years, with an annual rate of 6.1%. Seroconversion rates were higher in smokers (p = 0.02) and patients with a body mass index (BMI) over 25 kg/m² (p = 0.006). Patients who started natalizumab at age 35 or older had a shorter median time to seroconversion (p = 0.003), and most seroconversions occurred within the first three years. No significant associations were found with gender, prior immunosuppressive treatment, MS subtype, or MS age of onset.

CONCLUSION:

Anti-JCV seroconversion is more likely in patients who smoke, have a higher BMI, start natalizumab therapy after age 35, and within the first three years of treatment. For these high-risk patients, vigilant monitoring of anti-JCV antibodies is required.

172

News (Medical) associated with Natalizumab

05 Mar 2025

·www.prnewswire.com

Global Interferons Market is Predicted to Reach ~USD 14 Billion by 2032 | DelveInsight

The increasing occurrence of chronic and infectious diseases is the main driver of the rising demand for interferon. Furthermore, advancements in interferon production and ongoing research and development of innovative interferon therapies are key factors fueling the expansion of the interferon market from 2025 to 2032. LAS VEGAS, March 5, 2025 /PRNewswire/ -- DelveInsight's Interferons Market Insights report provides the current and forecast market analysis, individual leading interferons companies' market shares, challenges, interferons market drivers, barriers, trends, and key market interferons companies in the market. Key Takeaways from the Interferons Market Report As per DelveInsight estimates, North America is anticipated to dominate the global interferons market during the forecast period. In the application segment of the interferon market, the leukemia category captured a significant revenue share in 2024. Notable interferons companies such as Bayer AG, Amega Biotech, Biogen, Merck KGaA, Novartis AG, Pfizer Inc., F. Hoffmann-La Roche Ltd., Biosidus, AOP Orphan Pharmaceuticals GmbH, Reliance Life Sciences, and several others, are currently operating in the interferons market. In September 2022, Eiger BioPharmaceuticals, a commercial-stage biopharmaceutical company focused on the development of innovative therapies for hepatitis delta virus (HDV) and other serious diseases, provided an update on the status of its planned request for emergency use authorization (EUA) of peginterferon lambda for the treatment of patients with mild-to-moderate COVID-19 based on its most recent communications with the U.S. Food and Drug Administration (FDA). To read more about the latest highlights related to the interferons market, get a snapshot of the key highlights entailed in the Global Interferons Market Report Interferons Overview Interferons (IFNs) are a group of signaling proteins that play a critical role in the immune response, particularly in defending against viral infections and modulating the activity of immune cells. They are classified into three main types: Type I (such as IFN-α and IFN-β), Type II (IFN-γ), and Type III (IFN-λ). Type I interferons are primarily produced in response to viral infections and function by activating antiviral pathways in host cells, inhibiting viral replication, and enhancing the activity of natural killer (NK) cells. IFN-γ, the sole Type II interferon, is crucial for activating macrophages and promoting adaptive immune responses, particularly in bacterial and tumor immunity. Type III interferons share functional similarities with Type I IFNs but act more selectively on epithelial cells, making them important in mucosal immunity. Beyond their antiviral properties, interferons have significant roles in cancer immunotherapy and autoimmune diseases. They enhance antigen presentation, stimulate cytotoxic T cells, and modulate the tumor microenvironment, contributing to immune surveillance against malignancies. Clinically, recombinant interferons have been used to treat conditions such as hepatitis B and C, multiple sclerosis, and certain cancers. However, prolonged interferon therapy can lead to adverse effects, including flu-like symptoms, fatigue, and autoimmune complications. Recent research is focused on optimizing interferon-based therapies and combining them with immune checkpoint inhibitors or other immunomodulators to improve efficacy while minimizing toxicity. Interferons Market Insights North America holds the largest interferons market share due to a strong presence of biopharmaceutical companies, robust R&D investments, and high healthcare expenditure. The U.S. market, in particular, benefits from a well-established regulatory framework and widespread adoption of advanced biotherapeutics. Meanwhile, Europe follows closely, with key contributions from Germany, France, and the UK, where government support for biotech innovation and access to novel biologics drive market expansion. In the Asia-Pacific region, the interferon market is witnessing rapid growth, fueled by rising healthcare infrastructure, an increasing prevalence of infectious diseases, and government initiatives to boost biopharmaceutical production. China and India are emerging as major players, with domestic companies investing heavily in biosimilar development and expanding manufacturing capacities. Latin America and the Middle East & Africa are also showing potential, albeit at a slower pace, due to improving healthcare access and growing awareness of biologic treatments. However, market expansion in these regions is challenged by high drug costs and regulatory hurdles, which may impact the adoption of interferon therapies. To know more about why North America is leading the market growth in the interferons market, get a snapshot of the Interferons Market Outlook Interferons Market Dynamics The interferons market is driven by their critical role in treating viral infections, autoimmune diseases, and various cancers. Interferons (IFNs) are a class of cytokines that modulate the immune response, making them valuable in antiviral therapies (such as hepatitis B and C), multiple sclerosis, and oncology applications. The increasing prevalence of these diseases, along with rising research into novel interferon-based therapies, continues to fuel market growth. However, the market faces challenges due to the emergence of alternative therapies, such as monoclonal antibodies and small-molecule inhibitors, which offer higher efficacy and fewer side effects. One of the key factors influencing market dynamics is the shift from traditional interferon therapies to newer, more targeted treatments. For instance, in the treatment of hepatitis C, direct-acting antiviral agents (DAAs) have largely replaced interferon-based regimens due to their superior cure rates and reduced adverse effects. Similarly, in multiple sclerosis, oral therapies and monoclonal antibodies such as ocrelizumab and natalizumab have overshadowed interferon-beta treatments. Despite this, interferons remain relevant in certain applications, such as rare cancers and specific immune disorders where alternative treatments are not as effective. Another factor shaping the interferons market is the regulatory landscape. Interferons are biologic drugs, meaning they are subject to stringent approval processes and high production costs. The development of biosimilar interferons has the potential to make these therapies more accessible, especially in emerging markets. However, biosimilars face challenges in gaining market traction due to concerns about immunogenicity and physician preference for established brands. Companies investing in next-generation interferons with improved efficacy and safety profiles may have an opportunity to capture a share of this evolving market. Looking ahead, the future of the interferons market will be shaped by ongoing innovation, competitive pressures, and the need for cost-effective biologics. While traditional interferon therapies may continue to decline in some areas, their role in niche indications and combination therapies could sustain market demand. Companies focusing on improving delivery methods, reducing side effects, and exploring novel interferon applications in immuno-oncology and rare diseases may unlock new growth opportunities in this evolving landscape. Get a sneak peek at the interferons market dynamics @ Interferons Market Dynamics Analysis Interferons Market Assessment Interferons Market Segmentation Interferons Market Segmentation By Type: Alpha, Beta, and Gamma Interferons Market Segmentation By Application: Hepatitis B, Hepatitis C, Leukemia, Multiple Sclerosis, and Others Interferons Market Segmentation By Distribution Channel: Hospital Pharmacies, Retail Pharmacies, and Others Interferons Market Segmentation By Geography: North America, Europe, Asia-Pacific, and Rest of World Porter's Five Forces Analysis, Product Profiles, Case Studies, KOL's Views, Analyst's View Which MedTech key players in the interferons market are set to emerge as the trendsetter explore @ Interferons Companies Table of Contents Interested in knowing the interferons market by 2032? Click to get a snapshot of the Interferons Market Trends Related Reports Multiple Sclerosis Market Multiple Sclerosis Market Insights, Epidemiology, and Market Forecast – 2034 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 multiple sclerosis companies, including Immune Response BioPharma, Inc., Clene Nanomedicine, Sanofi, Merck Healthcare KGaA, TG Therapeutics, Inc., Apimeds Inc., Bayer HealthCare, Novartis, Biogen, Alkermes, Genentech, among others. Multiple Sclerosis Pipeline Multiple Sclerosis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key multiple sclerosis companies, including Novartis, Sanofi, Immunic, Biocad, Apimeds, Genentech (Roche), Merck, AB Science, Apurano Pharmaceuticals, Biogen, Tiziana Life Sciences, Worg Pharmaceuticals, Antisense Therapeutics, RemeGen, Atara Biotherapeutics, Contineum Therapeutics, Stem Cell Medicine Ltd., Ever Supreme Bio Technology Co., Ltd., ImCyse, among others. Chronic Hepatitis B Market Chronic Hepatitis B Market Insights, Epidemiology, and Market Forecast – 2034 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 chronic hepatitis B companies, including GlaxoSmithKline, Ionis Pharma, Beijing Continent Pharmaceutical, Ascletis Pharmaceuticals, Vir Biotechnology, Brii Biosciences, Janssen, Arrowhead Pharmaceuticals, among others. Chronic Hepatitis B Pipeline Chronic Hepatitis B Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key chronic hepatitis B companies, including Vedanta Biosciences, Gilead Sciences, Dong-A ST Co, Assembly Biosciences, Arbutus Biopharma, Vir Biotechnology, Antios Therapeutics, Ascletis Pharmaceuticals, Shanghai HEP Pharmaceutical, Romark Laboratories, Qilu Pharmaceutical, Golden Biotechnology, Sunshine Lake Pharma, Ascentage Pharma, GlaxoSmithKline, Janssen Sciences, Henlix, Enyo Pharma, Tasly Tianjin Biopharmaceutical, Brii Biosciences, Vaxine Pty Ltd, Vaccitech limited, Zhejiang Palo Alto Pharmaceuticals, Suzhou Ribo Life Science, PharmaEssentia, Nucorion Pharmaceuticals, Jiangsu HengRui Medicine, Enanta Pharmaceuticals, Chong Kun Dang Pharmaceutical, Guangzhou Lupeng Pharmaceutical, VenatoRx Pharmaceuticals, Zhimeng Biopharm, 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. Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Immunotherapy

05 Mar 2025

·www.pharmaceutical-technology.com

Sandoz said it expects net sales to grow by a mid-single digit percentage in constant currencies in 2025. Image credit: Shutterstock/ T. Schneider. Sandoz reported a 9% growth in net sales of generics and biosimilars to third parties for 2024, marking a strong first financial year as an independent company. After completing its spin-off from Novartis in October 2023, Sandoz has been busy launching new products and simplifying its business. Whilst generics made up the bulk of the Swiss company’s $10.4bn in net sales in 2024, biosimilars pushed more of the growth. Generics brought in $7.5bn for growth at constant exchange rates of 2%, whereas biosimilar sales grew 30% to bring in $2.8bn. Investor reaction to the earnings suggested that performance was in line with expectations. Shares in the company opened almost 1% higher following the announcement. Sandoz has a market cap of $19.2bn. Sandoz’s earnings report come at a time when geopolitical events have significantly impacted market fluctuations. The company issued a guidance on the potential fallout from trade tariffs imposed by the US government on Canada, Mexico, and China. Levies on imported goods could negatively impact the biopharma industry such as raising drug prices and worsening shortages. “The US accounts for just under 20% of our global revenues, as we are a European-based company with strong growth potential in the US, but not dependent on any one market. Potential tariffs on imports from China and Canada are included in our 2025 guidance. For Europe, it is still too early to model,” Sandoz CEO Richard Saynor said in a statement to Pharmaceutical Technology . Sandoz pointed to the uptake of its Humira biosimilar Hyrimoz in the US through a private-label agreement with CVS biosimilar subsidiary Cordavis as one of the drivers of its biosimilar business growth. Humira, AbbVie’s mega blockbuster, was once the world’s bestselling drug, bringing in revenue of $21.2bn in 2022, and the launch of several biosimilars has represented a sizeable loss-of-exclusivity value. Along with autoimmune diseases, Sandoz has been active in the ophthalmologic space. The US Food and Drug Administration (FDA) approved Sandoz’s Enzeevu (aflibercept-abzv), the drugmaker’s biosimilar for wet age-related macular degeneration (AMD), in August 2024. Despite battling for AMD market share against products from rivals Biocon Biologics and Samsung Bioepis, Sandoz consolidated its position in March 2024 with a $170m acquisition of Cimerli (ranibizumab-eqrn), a biosimilar approved for a range of retinal diseases. In its generics business, price erosion led to a decline in US sales, the company said. Sandoz also cited the divestment of its China operations as an offset to international growth. South Africa-based Aspen Pharmaceuticals bought Sandoz’s Chinese business for $100m at the tail-end of 2023. 2025 outlook During the call, Sandoz highlighted several strategic business decisions, including a reduction in the number of its internal manufacturing sites to 15, down from 18 in 2023. The company boosted the capacity at remaining sites and consolidated the number of its external suppliers. Saynor told Pharmaceutical Technology : “This allows us to simplify our supply chain and optimise capacity usage and processes. Ultimately, it helps us to secure supply, stabilise our cost basis, and increase patient access to critical medicines worldwide.” Looking ahead to 2025, Sandoz said it expects net sales to grow by a mid-single digit percentage in constant currencies. Sandoz has already launched Stelara biosimilar Pyzchiva (ustekinumab-ttwe) in the US and has eyes on launching the Tysabri biosimilar Tyruko in the country in 2025 too. Whilst experiencing significant growth, the biosimilar market has been saturated with lawsuits. Johnson & Johnson (J&J) recently, for example, sued Samsung Bioepis over a breach of contract for Stelara. Nevertheless, GlobalData forecasts biosimilar sales to increase from 5.7% in 2022 to 18.3% in 2032 through the eight major markets (8MM: US, France, Germany, Italy, Spain, UK, Japan, and China). GlobalData is the parent company of Pharmaceutical Technology.

AcquisitionDrug ApprovalBiosimilarPatent Expiration

03 Mar 2025

·www.prnewswire.com

Simple algorithm helps improve treatment, reduce disparities in MS

MINNEAPOLIS, March 3, 2025 /PRNewswire/ -- A simple treatment algorithm may help reduce treatment disparities for Hispanic and Black people with multiple sclerosis (MS), according to a preliminary study released March 3, 2025, that will be presented at the American Academy of Neurology's 77th Annual Meeting taking place April 5–9, 2025, in San Diego and online. "Studies show Hispanic and Black people have higher levels of disability than white people but are not given prescriptions for the newer, more effective treatments as often as white people are," said study author Annette Langer-Gould, MD, PhD, of Kaiser Permanente Southern California in Los Angeles and a member of the American Academy of Neurology. "We're excited that we've found a straightforward way to rapidly increase the use of these medications among all three groups, greatly improving their health." The program uses an algorithm to determine the best disease-modifying treatments for people with MS. The algorithm uses readily available clinical factors such as weakness and bladder dysfunction, and also considers social factors such as out-of-pocket costs, transportation barriers, childcare and work schedules, but not race and ethnicity. The intervention can match people to newer treatments that are highly effective at reducing MS relapses, including medications like natalizumab, rituximab and ofatumumab. Relapses are when MS symptoms like numbness, weakness, stiffness or vision problems appear for at least 24 hours. Because some of these drugs are expensive, not everyone with MS may be able to use them, which can widen health disparities. The study involved 1,741 Hispanic people, 978 Black people and 3,400 white people with MS who were being treated with disease-modifying therapies. Three years before the start of the study, Hispanic people had a higher annual relapse rate than white people, with 245 relapses compared to 156 relapses per 1,000 person-years. Person-years represent both the number of people in the study and the amount of time each person spends in the study. Black people had a higher relapse rate than white people during one year of the study. Over the 12-year study, researchers found all three groups had an increased use of highly effective therapies, primarily rituximab, which is less expensive and can be given once a year or less. For Hispanic people, there was an 89% increase in use of highly effective therapies, for Black people an 87% increase, and for white people, 83%. After adjusting for age and sex, researchers reported a decline in the annual relapse rate for each group. The decline was greatest among Hispanic people at 90% fewer relapses per year, white people at 86%, and Black people at 82%. By the end of the study, there was no longer a significant difference in the annual relapse rate among Hispanic, Black and white people. "It is encouraging that our program led to more effective treatments for people with MS resulting in a large reduction in relapse rates among Hispanic, Black and white people," said Langer-Gould. "We show that using an algorithmic approach to increase the use of highly effective medications, particularly an affordable one like rituximab, can reduce racial and ethnic disparities in MS and greatly improve outcomes for all people with relapsing forms of MS." A limitation of the study was that it did not assess long-term disability or whether starting highly effective treatments at diagnosis is more beneficial than delaying these treatments until later in the disease course. Discover more about multiple sclerosis at BrainandLife.org, from the American Academy of Neurology. This resource also offers a magazine, podcast, and books that connect patients, caregivers and anyone interested in brain health with the most trusted information, straight from the world's leading experts in brain health. Follow Brain & Life® on Facebook, X, and Instagram. The American Academy of Neurology is the leading voice in brain health. As the world's largest association of neurologists and neuroscience professionals with more than 40,000 members, the AAN provides access to the latest news, science and research affecting neurology for patients, caregivers, physicians and professionals alike. The AAN's mission is to enhance member career fulfillment and promote brain health for all. A neurologist is a doctor who specializes in the diagnosis, care and treatment of brain, spinal cord and nervous system diseases such as Alzheimer's disease, stroke, concussion, epilepsy, Parkinson's disease, multiple sclerosis, headache and migraine. Explore the latest in neurological disease and brain health, from the minds at the AAN at AAN.com or find us on Facebook, X, Instagram, LinkedIn, and YouTube. SOURCE American Academy of Neurology WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical Result

100 Deals associated with Natalizumab

External Link

KEGG	Wiki	ATC	Drug Bank
D06886	Natalizumab	L04AA23	DB00108

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Crohn Disease	United States	Biogen, Inc.	14 Jan 2008
Multiple Sclerosis, Relapsing-Remitting	European Union	Biogen Netherlands BV	27 Jun 2006
Multiple Sclerosis, Relapsing-Remitting	Iceland	Biogen Netherlands BV	27 Jun 2006
Multiple Sclerosis, Relapsing-Remitting	Liechtenstein	Biogen Netherlands BV	27 Jun 2006
Multiple Sclerosis, Relapsing-Remitting	Norway	Biogen Netherlands BV	27 Jun 2006
Multiple Sclerosis	United States	Biogen, Inc.	23 Nov 2004

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Multiple Sclerosis, Secondary Progressive	Phase 3	United States	Biogen, Inc.	13 Sep 2011
Multiple Sclerosis, Secondary Progressive	Phase 3	Belgium	Biogen, Inc.	13 Sep 2011
Multiple Sclerosis, Secondary Progressive	Phase 3	Canada	Biogen, Inc.	13 Sep 2011
Multiple Sclerosis, Secondary Progressive	Phase 3	Czechia	Biogen, Inc.	13 Sep 2011
Multiple Sclerosis, Secondary Progressive	Phase 3	Denmark	Biogen, Inc.	13 Sep 2011
Multiple Sclerosis, Secondary Progressive	Phase 3	Finland	Biogen, Inc.	13 Sep 2011
Multiple Sclerosis, Secondary Progressive	Phase 3	France	Biogen, Inc.	13 Sep 2011
Multiple Sclerosis, Secondary Progressive	Phase 3	Germany	Biogen, Inc.	13 Sep 2011
Multiple Sclerosis, Secondary Progressive	Phase 3	Ireland	Biogen, Inc.	13 Sep 2011
Multiple Sclerosis, Secondary Progressive	Phase 3	Israel	Biogen, Inc.	13 Sep 2011

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00027300 (AFFIRM, Pubmed \| Mult Scler) Manual	Phase 3	Multiple Sclerosis, Relapsing-Remitting	-	Natalizumab	okwtsjzyfj(ffmpyqbqtl) = wxbpuqtlov abrktcvlzr (ryrpxchxgc ) View more	Positive	12 Mar 2024
				placebo	-
ACTRIMS2024	Not Applicable	Multiple sclerosis relapse	69	Natalizumab	fzxugajzaw(bqutreleie) = wbfhsnwnld kdqtpolcks (ehfcoddure ) View more	Positive	01 Mar 2024
				Ocrelizumab	fzxugajzaw(bqutreleie) = ihseutxqyn kdqtpolcks (ehfcoddure ) View more
ACTRIMS2024	Not Applicable	Multiple sclerosis relapse John Cunningham Virus (JCV) serology	-	Extended Interval Dosing (EID) Natalizumab	vsbxqohijj(chpcolbfeq) = qjpcugmhsk jfopfssrsz (murdcsnbjx ) View more	Positive	29 Feb 2024
				Standard Interval Dosing (SID) Natalizumab	vsbxqohijj(chpcolbfeq) = rewiwccadu jfopfssrsz (murdcsnbjx ) View more
NCT05304520 (SISTER, Pubmed \| Ther Adv Neurol Disord) Manual	Not Applicable	Multiple Sclerosis, Relapsing-Remitting	262	Subcutaneous natalizumab	tbcovnxntl(pmgwkvdxhv) = zllqrzkvfo ysllfcetus (qoscvxblas )	Positive	01 Jan 2024
				Intravenous natalizumab	tbcovnxntl(pmgwkvdxhv) = bceoxqjqhf ysllfcetus (qoscvxblas ) View more
ECTRIMS2023	Not Applicable	Multiple Sclerosis	-	Natalizumab-treated POMS (N-POMS)	zdouurjelp(axnmutjolg) = qwdeckqoga bmcugctwfr (nkozgpzyya )	Positive	30 Sep 2023
				Fingolimod-treated POMS (F-POMS)	zdouurjelp(axnmutjolg) = nrknidjczk bmcugctwfr (nkozgpzyya )
ECTRIMS2023	Not Applicable	Multiple Sclerosis	414	Cladribine (CLD)	iodnrukjaa(cawynafdxd) = lhanxhbwee ndlzjpronq (ymbwlxcgwe ) View more	Negative	30 Sep 2023
				Alemtuzumab (ALZ)	iodnrukjaa(cawynafdxd) = lvrpztzlhv ndlzjpronq (ymbwlxcgwe ) View more
ECTRIMS2023	Not Applicable	Infectious Diseases	-	Rituximab	kkqjuppzua(gkbqhornnc) = lelogoifhj xjeibjfpcj (jlrhaiuesq ) View more	Negative	30 Sep 2023
				Natalizumab	kkqjuppzua(gkbqhornnc) = ozoutrfgcz xjeibjfpcj (jlrhaiuesq ) View more
ECTRIMS2023	Not Applicable	Multiple Sclerosis, Relapsing-Remitting	86	Natalizumab IV	fjewtskkuf(fcxqmkhzuy) = wctgemvyzu adoodwjybj (bdvsvtasbd ) View more	-	30 Sep 2023
				Natalizumab SC	xyyaxyyxzd(otvmholbam) = nvkfeqfden aawvgfwvcz (ejxcyuyoov )
ECTRIMS2023	Not Applicable	anti-JCV antibodies	-	natalizumab (StratifyJCVTM testing by Unilabs)	sbiuqppsbw(vmukmoexuc) = rvlankhnoy ikwayvikic (zghwdozmrs ) View more	-	30 Sep 2023
NOVA trial (ECTRIMS2023)	Not Applicable	JCV+	220	Natalizumab (Extended Interval Dosing (EID))	ngbilfnoyl(wnjrglcvsv) = One case of PML occurred in each group knlnkbzgkg (zckambzexz ) View more	Negative	30 Sep 2023
				Natalizumab (Standard Dosing)

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