Latest news with #IgG4-RD
Yahoo
3 days ago
- Business
- Yahoo
IgG4-Related Disease Market Insights, Epidemiology, and Forecast to 2034: UPLIZNA and Obexelimab Expected to Compete Strongly
Dublin, June 03, 2025 (GLOBE NEWSWIRE) -- The "IgG4-Related Disease - Market Insight, Epidemiology, and Market Forecast - 2034" report has been added to offering. This report delivers an in-depth understanding of historical and forecasted epidemiology as well as market trends in the United States, EU4 (Germany, France, Italy, Spain) and the United Kingdom, and Japan. The report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM market size from 2020 to 2034. The report also covers current treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential. Key Highlights from the Report There were nearly 148,970 diagnosed prevalent cases of IgG4-RD in 7MM in 2024. Among these, the US accounted for the highest number of diagnosed prevalent cases of IgG4-RD. Contrary to the scenario in the US and EU4, and the UK, there have been multiple studies conducted in Japan stating the diagnosed prevalence; therefore, based on 10-year cumulative diagnosed prevalence estimates from the National Database in Japan, along with evidence around drastic increase in the diagnosis of IgG4 related disease from 2015-2018, there were ~38,690 diagnosed cases in 2024 in Japan. Almost 20-30% of the diagnosed IgG4 patients do not undergo any treatment by systemic therapies, as they opt for either surgery or are under a watchful waiting strategy. There are no specific drugs to cure IgG4-RD due to unclear pathophysiology completely, and no approved therapies are available. The main treatment is corticosteroids like prednisone to manage inflammation and symptoms. If the disease relapses or doesn't respond, immunosuppressants like azathioprine or methotrexate may be used to reduce steroid dependence. Rituximab, an anti-CD20 monoclonal antibody, has also shown effectiveness in controlling inflammation and slowing disease progression. Glucocorticoids remain the first-line therapy. The current constrained pipeline features three emerging therapies: UPLIZNA (Amgen), obexelimab (Zenas BioPharma and Bristol Myers Squibb), and rilzabrutinib (Sanofi). Among these emerging therapies, UPLIZNA and obexelimab are expected to compete with each other strongly. The anticipated April 2025 approval of UPZILNA will transform the IgG4-RD market, marking the first-ever approved therapy for this underserved condition. It will redefine the treatment landscape, drive higher diagnosis rates, and shape commercial dynamics through pricing and physician adoption. However, market education, real-world validation, and future competition will influence its long-term impact. Rilzabrutinib, a Phase II therapy, represents a promising oral therapy targeting B-cell signaling pathways. If approved, it could disrupt the IV/SC biologic market by offering a more convenient, self-administered alternative. In 2024, the total market size of IgG4-RD in 7MM was nearly USD 170 million. The market size is expected to observe significant growth after the approval of potential emerging therapies in the pipeline. IgG4-RD EpidemiologyAs the market is derived using a patient-based model, the IgG4-RD epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total diagnosed prevalent cases of IgG4-RD, gender-specific diagnosed prevalent cases of IgG4-RD, and age-specific diagnosed prevalent cases of IgG4-RD in the 7MM covering the United States, EU4 countries (Germany, France, Italy, Spain) and the United Kingdom, and Japan from 2020 to 2034. In 2024, the total diagnosed prevalent cases of IgG4-RD in the United States were approximately 56,800 cases, projected to increase during the forecast period (2025-2034). In 2024, gender-specific diagnosed prevalent cases accounted for approximately 39,100 and 17,700 cases for males and females, respectively, in the US. The total diagnosed prevalent cases of IgG4-RD in EU4 and the UK were approximately 53,550 in 2024. Males accounted for approximately 38,850 cases, and 14,750 cases in females. We have considered six age groups for the categorization of age groups, i.e., 0-17 years, 18-29 years, 30-44 years, 45-64 years, 65-74 years, and =75 years. As per our analysis, a higher percentage of diagnosed prevalent cases was observed in the age group =75 years in Japan. In 2024, the age-specific diagnosed prevalent cases of IgG4-RD in Japan were approximately 12,800 cases in the age group =75 years. The cases will increase during the forecast period (2025-2034). Drug ChaptersThe drug chapter segment of the IgG4-RD report encloses a detailed analysis of IgG4-RD marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also helps understand the IgG4-RD clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press Drugs Obexelimab (XmAb5871): Zenas BioPharma and Bristol Myers SquibbObexelimab (XmAb5871) is a bifunctional monoclonal antibody designed to bind both CD19 and Fc?RIIb, which are broadly present across B-cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. This unique mechanism of action and self-administered SC injection regimen may broadly and effectively address the pathogenic role of B-cell lineage in chronic autoimmune Zenas is conducting multiple Phase II and Phase III trials of obexelimab in several autoimmune diseases, including IgG4-RD, multiple sclerosis, systemic lupus erythematosus, and warm autoimmune hemolytic anemia. In August 2023, The Lancet Rheumatology published findings from a Phase II study evaluating obexelimab for the treatment of patients with IgG4-RD. Based on these results, a Phase III study in patients with IgG4-RD is ongoing to investigate further the efficacy and safety of obexelimab administered as an SC (inebilizumab): AmgenUPLIZNA is a humanized monoclonal antibody that causes targeted and sustained depletion of key cells that contribute to the underlying disease process (autoantibody-producing CD19+ B cells, including plasmablasts and some plasma cells). After two initial infusions, patients need one dose of UPLIZNA every 6 months. UPLIZNA is currently approved for the treatment of Neuromyelitis Optica. Currently, the drug has completed its Phase III results, and the FDA has granted a PDUFA action date of April 3, is anticipated to be the first approved cornerstone therapy for managing this complex and often debilitating condition, providing significant benefits to patients while addressing a critical gap in current treatment options for IgG4-RD. In the future, the drug could face competition with the approval of obexelimab, which operates through a bifunctional targeting mechanism of Class InsightsThe current IgG4-RD emerging landscape has only three drugs. Among them, obexelimab (bifunctionally) and UPLIZNA target CD-19. Targeting CD19, a protein found in B cells, shows promise as a treatment for IgG4-RD by depleting B cells, which are thought to play a role in the disease's pathogenesis. Specifically, UPLIZNA, a CD19-targeted antibody, has demonstrated efficacy in reducing flares and achieving remission in IgG4-RD OutlookAs the etiology of IgG4-RD is unclear and still being studied, no particular medications can cure the disease. For people with IgG4-RD, there are no approved treatments on the market at this time. The criteria for identifying the disease caused by IgG4 levels and patient treatment recommendations were recently detailed in the guidelines released by the "International Consensus Guidance Statement on the Management and Treatment of IgG4-RD."Patients with IgG4-RD that are active or untreated typically get glucocorticoids as their first line of therapy. Depending on the severity of the condition and the urgency of the situation, remission induction is frequently started with 30-40 mg/day of prednisone or a weight-adjusted dosage of 0.6 mg/kg of body weight each certain instances, conventional "Disease-Modifying Anti-Rheumatic Drugs" (DMARDs) are utilized to treat IgG4-RD. Plasmablasts are the first cell in any rheumatologic disorder to serve as an effective biomarker, and tailored therapy in B-cell employs total plasmablast concentration to track disease numerous potential therapies are being investigated to manage IgG4-RD, it is safe to predict that the treatment space will experience significant reconstitution during the forecast period. However, the challenges of pricing and reimbursement accompanied by will decide the fate of all these pipeline therapies and the impact they will have on overall revenue players such as Zenas Biopharma, Amgen, and Sanofi are evaluating their lead candidates in different stages of clinical development, respectively. They aim to investigate their products to treat IgG4-RD. In 2024, the US captured the highest market share, i.e., nearly USD 90 million out of all the 7MM countries. EU4 and the UK accounted for nearly USD 80 million of the market share, and Germany accounted for the highest share in Europe in 2024. In Japan, the IgG4-RD market size accounted for nearly USD 6 million and is expected to increase at a significant CAGR during the forecast period (2025-2034). The lack of an established regulatory precedent and standardized endpoints for IgG4-RD trials poses approval risks. Additionally, payer resistance to high-cost biologics may slow adoption, especially if off-label rituximab remains a cost-effective alternative. However this will not be an issue in Japan as rituximab is not yet permitted for use to treat IgG4-RD in Japan due to Japanese medical insurance reasons. Key Updates In November 2024, Zenas BioPharma announced the completion of its targeted enrollment for the Phase III INDIGO trial of its lead product candidate, obexelimab, for the treatment of patients with IgG4-RD. In November 2024, Zenas BioPharma announced that the company anticipates reporting topline results for the INDIGO trial by the end of 2025. In August 2024, Amgen announced that the US FDA had granted Breakthrough Therapy Designation (BTD) to UPLIZNA for the treatment of IgG4-RD based on data from the MITIGATE study. In February 2025, Amgen announced that the FDA had accepted the regulatory submission for the Phase III MITIGATE study under priority review, with a PDUFA action date of April 3, 2025. IgG4-RD Drugs UptakeThis section focuses on the uptake rate of potential drugs expected to be launched in the market during 2020-2034. The landscape of IgG4-RD treatment has experienced a profound transformation with the uptake of novel drugs. These innovative therapies are redefining standards of care. Furthermore, the increased uptake of these transformative drugs is a testament to the unwavering dedication of physicians, oncology professionals, and the entire healthcare community in their tireless pursuit of advancing cancer care. This momentous shift in treatment paradigms is a testament to the power of research, collaboration, and human ActivitiesThe report provides insights into different therapeutic candidates in Phase III, Phase II/III, Phase II, Phase I/II, and Phase I. It also analyzes key players involved in developing targeted ActivitiesThe report covers detailed information on collaborations, acquisitions and mergers, licensing, and patent details for IgG4-RD emerging ViewsTo keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Some of the leaders like MD, PhD, Research Project Manager, Director, and others. Their opinion helps to understand and validate current and emerging therapies and treatment patterns or IgG4-RD market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet analysts connected with 20+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as the Massachusetts General Hospital, Hopital La Timone, Harvard Medical School, Hospital Universitari Vall d'Hebron, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, etc., were contacted. Their opinion helps understand and validate IgG4-RD epidemiology and market trends. Reasons to Buy The report will help in developing business strategies by understanding trends shaping and driving IgG4-RD. To understand the future market competition in the IgG4-RD market and an Insightful review of the SWOT analysis of IgG4-RD. Organize sales and marketing efforts by identifying the best opportunities for IgG4-RD in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan. Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors. Organize sales and marketing efforts by identifying the best opportunities for the IgG4-RD market. To understand the future market competition in the IgG4-RD market. For more information about this report visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
USA Today
23-04-2025
- Health
- USA Today
She saw 26 doctors and had 37 procedures with no diagnosis in sight. Then, an answer.
She saw 26 doctors and had 37 procedures with no diagnosis in sight. Then, an answer. Show Caption Hide Caption How important is your family medical history? If you've been to a doctor before, you've probably been asked about your family medical history. How important is it actually? unbranded - Lifestyle Nika Beamon thought she was going to die. The former college athlete always played high-impact sports. Rugby, ice hockey, you name it. Always knocked down but toughing it out. By the time she was a senior at Boston College, though, toughing it out grew impossible. Waking up everyday was a struggle. Aches appeared out of nowhere, even when she wasn't exercising. She ran spontaneous fevers, like she was fighting an infection. Test after test – for mono, for anything – all failed to spit out a diagnosis. She had no family history of diseases; her brothers were perfectly healthy. But everyone agreed on one thing: Something was up. "I did not have any doctor who didn't think nothing was wrong," the now 52-year-old award-winning journalist says. "Everybody thought something was wrong. They just didn't know what it was." Fatigue and joint pain plagued her 20s. She suffered two strokes by the time she turned 35. Her lymph nodes swelled constantly, but biopsies showed no cancer. "I don't know who this is, but this doesn't seem like me," she adds. "I felt like I was aging rapidly. It was like, as if you went from 20 to 50 in a day." Beamon set out on a journey, and 26 doctors, 37 procedures and more than 17 years later, a rheumatologist finally cracked the confounding code: She had immune disorder IgG4-related disease, and all she needed was a blood test to confirm it. "There's no way I could have been to this many doctors and had this much blood drawn and nobody saw it," Beamon recalls. "(Her doctor) said, 'Well, they wouldn't be testing for it unless there was a reason.'" I got 14 tests done at this resort: I didn't need most of them. 'Most patients do well' IgG4-RD is an immune-mediated disorder. When someone has it, their immune system goes into overdrive, producing more antibodies (or immunoglobulins, hence the name) than necessary that disrupt typical organ function. "It's not cancers or anything," says Dr. Arezou Khosroshahi, associate professor at Emory University School of Medicine. "It's just that they are confused and they are reacting to something." The disease itself is not deadly, but left untreated, the antibodies can infiltrate different parts of the body like the pancreas, lung or liver. For example, if an accumulation of cells block the bile ducts, a patient can develop cirrhosis, or liver damage. The same pattern may pop up across different organs. Another wrinkle: Patients may be asymptomatic. If you catch it on time, a patient can live a normal life with regular follow-up appointments. But if someone's organ(s) already had severe dysfunction, you'll have to treat any associated consequential conditions, too. "I can't emphasize enough, this is very important, because people think, 'Oh, I've got a steroid and I feel much better, so I don't need treatment,' but then they come back two years later with significant damage. But in general, if this disease is diagnosed on time and treated, most patients do well." It's a challenging diagnosis, as the disease mimics other conditions. A majority of the time, if the cell accumulation turns into a mass, a doctor will do a biopsy to make sure it's not cancer. As more awareness of the disease grows, a radiologist might look at a CT scan and notice a similar pattern of inflammation or swelling across multiple organ systems that put IgG4-RD into a diagnosis differential. It mostly affects middle-aged and older men, though anyone can have it regardless of age, gender, race or ethnicity. Japanese gastroenterologists first recognized the condition in 2006, with Khosroshahi and colleagues at Massachusetts General Hospital identifying it in 2008. The disease was officially named in 2012 at the premier symposium focused on IgG4-RD. In case you need: Boost your immune system to fight germs 'You still have good days and bad days' Beamon takes medication and sees all kinds of doctors today to keep her organs in check. She started out with steroids to keep her inflammation down, but they're notorious for rough side effects, not meant to be taken long-term. IgG4-RD has been typically treated with a taper dose of a steroid like prednisone, followed by off-label immunosuppressive medications. The FDA recently approved new drug Uplizna to treat IgG4-RD, the first to treat the specific condition. It's a monoclonal antibody that targets certain B-cells to inhibit production of IgG4; in a clinical trial, it had an 87% reduction of flare-ups of the disease. "You still have good days and bad days, and that's the thing," Beamon says of how she currently lives with the disorder. "Depends on when you have a flare or the inflammation is high." She's coped well with a supportive online community, particularly after she began documenting her journey and writing a book: "Misdiagnosed: The Search for Dr. House." Beamon hopes anyone searching for a diagnosis advocates for themselves, keeps track of their medical records and brings loved ones to appointments with them. Don't think your doctor knows more about your body than you do, either. Still, she doesn't blame anyone for not figuring out her IgG4-RD sooner. "I found it when I found the right person who looked outside the box and said, 'forget what she looks like. Forget what they're telling you. Let me just look at what the documents tell me that she might have' and that's how we got there," she says. "But I don't think it was anybody's fault." Her biggest takeaway, though – apart from do not Google your symptoms too much, because every website will tell you you're dying – keep the faith. "There's always a doctor out there that can help you. You just have to find the right one."
Yahoo
03-04-2025
- Health
- Yahoo
US FDA approves Amgen's Uplizna as first treatment for rare immune disorder
By Deena Beasley, Mariam Sunny and Siddhi Mahatole (Reuters) -The U.S. Food and Drug Administration has approved expanded use of Amgen's drug, Uplizna, to help reduce the risk of flares in patients with a rare immune system-related condition, the regulator said on Thursday. The drug, also known as inebilizumab, has now become the first FDA-approved treatment for Immunoglobulin G4-related disease (IgG4-RD), a rare condition in which an overactive immune system can lead to inflammation and scarring in various organs, including the pancreas, liver and kidneys. Uplizna, given by infusion, is designed to bind to a protein located on the surface of B cells, the underlying inflammatory cause of IgG4-RD and other autoimmune conditions. "By removing or depleting these B cells throughout the body, both in the circulating blood and in the tissue, there's a chance for Uplizna to confer a real benefit," said Jay Bradner, Amgen's head of research and development. Around 20,000 people in the U.S. suffer from the condition, he said. The approval was based on data from a late-stage study in which Uplizna helped reduce the risk of flares by 87% compared to a placebo. "This would be a fairly compelling drug that is infrequent, fairly safe, and very effective," TD Cowen analyst Yaron Werber told Reuters ahead of the decision. Werber estimates Uplizna to generate global peak sales of $1.3 billion by 2030 for IgG4-RD alone. Uplizna, which was already approved for a rare, severe neuroinflammatory disease called neuromyelitis optica spectrum disorder, brought in sales of $379 million in 2024. Steroids — usually used to manage IgG4-RD — have many negative effects on patients, including mood changes, weight gain and osteoporosis, said Dr. Matthew Baker, associate division chief of immunology and rheumatology at Stanford University. "The goal with a treatment like this is to definitely minimize steroid exposure, and I think it certainly will do that," Dr. Baker said. Sign in to access your portfolio
Bloomberg
03-04-2025
- Health
- Bloomberg
Amgen Wins FDA Nod for Uplizna to Treat Rare Disease
US regulators approved Amgen Inc. 's Uplizna as the first and only treatment for a rare inflammatory condition that causes tumor-like growths in organs. Uplizna was first approved in 2020 to treat another rare disease that affects the optic nerve and spinal cord. On Thursday, the US Food and Drug Administration cleared it for immunoglobulin G4-related disease, or IgG4-RD, after the treatment received Breakthrough Therapy designation to expedite the approval process.
Reuters
03-04-2025
- Health
- Reuters
US FDA approves Amgen's Uplizna as first treatment for rare immune disorder
April 3 (Reuters) - The U.S. Food and Drug Administration has approved expanded use of Amgen's (AMGN.O), opens new tab drug, Uplizna, to help reduce the risk of flares in patients with a rare immune system-related condition, the regulator said on Thursday. The drug, also known as inebilizumab, has now become the first FDA-approved treatment for Immunoglobulin G4-related disease (IgG4-RD), a rare condition in which an overactive immune system can lead to inflammation and scarring in various organs, including the pancreas, liver and kidneys. Keep up with the latest medical breakthroughs and healthcare trends with the Reuters Health Rounds newsletter. Sign up here. Uplizna, given by infusion, is designed to bind to a protein located on the surface of B cells, the underlying inflammatory cause of IgG4-RD and other autoimmune conditions. "By removing or depleting these B cells throughout the body, both in the circulating blood and in the tissue, there's a chance for Uplizna to confer a real benefit," said Jay Bradner, Amgen's head of research and development. Around 20,000 people in the U.S. suffer from the condition, he said. The approval was based on data from a late-stage study in which Uplizna helped reduce the risk of flares by 87% compared to a placebo. "This would be a fairly compelling drug that is infrequent, fairly safe, and very effective," TD Cowen analyst Yaron Werber told Reuters ahead of the decision. Werber estimates Uplizna to generate global peak sales of $1.3 billion by 2030 for IgG4-RD alone. Uplizna, which was already approved for a rare, severe neuroinflammatory disease called neuromyelitis optica spectrum disorder, brought in sales of $379 million in 2024. Steroids — usually used to manage IgG4-RD — have many negative effects on patients, including mood changes, weight gain and osteoporosis, said Dr. Matthew Baker, associate division chief of immunology and rheumatology at Stanford University. "The goal with a treatment like this is to definitely minimize steroid exposure, and I think it certainly will do that," Dr. Baker said.
