Latest news with #Sotatercept
Yahoo
31-03-2025
- Health
- Yahoo
Sotatercept FAERS study highlights emerging safety signals in PAH treatment
At the 2025 American College of Cardiology (ACC) meeting in Chicago, new real-world safety data were presented on sotatercept, a novel fusion protein for pulmonary arterial hypertension (PAH). A retrospective analysis of the FDA Adverse Event Reporting System (FAERS) revealed key adverse events (AEs) associated with sotatercept, including cerebrovascular accidents (CVAs), flushing, diarrhoea, neutropenia, and asthenia. The study emphasised a higher incidence of AEs in elderly patients (65–85 years), highlighting the need for vigilant monitoring in this population. PAH is a rare and progressive disease characterised by increased pulmonary vascular resistance, ultimately leading to right heart failure. Despite therapeutic advancements, PAH remains associated with high morbidity and mortality, necessitating the development of new disease-modifying agents. Sotatercept, a first-in-class activin signalling inhibitor, has demonstrated significant improvements in exercise capacity and haemodynamic parameters in clinical trials. However, its long-term safety profile in broader patient populations is still being evaluated. The FAERS analysis, which included 11 reported AEs as of June 2024, found that CVAs, flushing, diarrhoea, and neutropenia each accounted for 18.18% of reported cases. The age-based analysis revealed that 54.55% of AEs occurred in patients aged 65–85 years, with fewer incidents reported in younger cohorts. While no statistically significant differences were observed in AEs across organ system groups, the findings underscore potential safety concerns, particularly for elderly PAH patients. Key opinion leaders (KOLs) have previously emphasised sotatercept's transformative impact on PAH management. A European KOL noted: "Sotatercept is probably the most important development in PAH over the past ten years. It will change the complete treatment landscape and positioning of other compounds in the treatment algorithm." This statement highlights the significant clinical and commercial implications of sotatercept's entry into the PAH treatment paradigm. From a pharmaceutical strategy perspective, the FAERS findings introduce several critical considerations. First, the emergence of cerebrovascular events, although limited in frequency, may influence risk-benefit assessments during future regulatory reviews and labelling decisions. This could lead to targeted safety monitoring requirements or risk management plans (RMPs), particularly for older patients. Secondly, while sotatercept is positioned as an add-on therapy, the magnitude of its clinical benefits raises the possibility of earlier-line use. This could disrupt the current PAH treatment sequencing and challenge the market positioning of established endothelin receptor antagonists (ERAs) and phosphodiesterase-5 inhibitors (PDE5is). Lastly, the real-world safety signals from FAERS may prompt payers to introduce stricter prior authorisation criteria or outcomes-based agreements, tying reimbursement to patient outcomes to mitigate potential safety risks. Despite the identified AEs, sotatercept's novel mechanism of action and clinically meaningful efficacy gains position it as a valuable addition to the PAH treatment landscape. As longer-term real-world data and larger post-marketing studies become available, the comprehensive safety profile of sotatercept will become clearer, helping to define its optimal role in PAH management. "Sotatercept FAERS study highlights emerging safety signals in PAH treatment" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Yahoo
31-03-2025
- Health
- Yahoo
Sotatercept FAERS study highlights emerging safety signals in PAH treatment
At the 2025 American College of Cardiology (ACC) meeting in Chicago, new real-world safety data were presented on sotatercept, a novel fusion protein for pulmonary arterial hypertension (PAH). A retrospective analysis of the FDA Adverse Event Reporting System (FAERS) revealed key adverse events (AEs) associated with sotatercept, including cerebrovascular accidents (CVAs), flushing, diarrhoea, neutropenia, and asthenia. The study emphasised a higher incidence of AEs in elderly patients (65–85 years), highlighting the need for vigilant monitoring in this population. PAH is a rare and progressive disease characterised by increased pulmonary vascular resistance, ultimately leading to right heart failure. Despite therapeutic advancements, PAH remains associated with high morbidity and mortality, necessitating the development of new disease-modifying agents. Sotatercept, a first-in-class activin signalling inhibitor, has demonstrated significant improvements in exercise capacity and haemodynamic parameters in clinical trials. However, its long-term safety profile in broader patient populations is still being evaluated. The FAERS analysis, which included 11 reported AEs as of June 2024, found that CVAs, flushing, diarrhoea, and neutropenia each accounted for 18.18% of reported cases. The age-based analysis revealed that 54.55% of AEs occurred in patients aged 65–85 years, with fewer incidents reported in younger cohorts. While no statistically significant differences were observed in AEs across organ system groups, the findings underscore potential safety concerns, particularly for elderly PAH patients. Key opinion leaders (KOLs) have previously emphasised sotatercept's transformative impact on PAH management. A European KOL noted: "Sotatercept is probably the most important development in PAH over the past ten years. It will change the complete treatment landscape and positioning of other compounds in the treatment algorithm." This statement highlights the significant clinical and commercial implications of sotatercept's entry into the PAH treatment paradigm. From a pharmaceutical strategy perspective, the FAERS findings introduce several critical considerations. First, the emergence of cerebrovascular events, although limited in frequency, may influence risk-benefit assessments during future regulatory reviews and labelling decisions. This could lead to targeted safety monitoring requirements or risk management plans (RMPs), particularly for older patients. Secondly, while sotatercept is positioned as an add-on therapy, the magnitude of its clinical benefits raises the possibility of earlier-line use. This could disrupt the current PAH treatment sequencing and challenge the market positioning of established endothelin receptor antagonists (ERAs) and phosphodiesterase-5 inhibitors (PDE5is). Lastly, the real-world safety signals from FAERS may prompt payers to introduce stricter prior authorisation criteria or outcomes-based agreements, tying reimbursement to patient outcomes to mitigate potential safety risks. Despite the identified AEs, sotatercept's novel mechanism of action and clinically meaningful efficacy gains position it as a valuable addition to the PAH treatment landscape. As longer-term real-world data and larger post-marketing studies become available, the comprehensive safety profile of sotatercept will become clearer, helping to define its optimal role in PAH management. "Sotatercept FAERS study highlights emerging safety signals in PAH treatment" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Globe and Mail
12-03-2025
- Business
- Globe and Mail
Pulmonary Arterial Hypertension Clinical Trials and Studies: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies
DelveInsight's, 'Pulmonary Arterial Hypertension Pipeline Insight' report provides comprehensive insights about 55+ companies and 55+ pipeline drugs in Pulmonary Arterial Hypertension pipeline landscape. It covers the Pulmonary Arterial Hypertension pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Pulmonary Arterial Hypertension therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Explore the comprehensive insights by DelveInsight and stay ahead in understanding the Pulmonary Arterial Hypertension Treatment Landscape. Click here to read more @ Pulmonary Arterial Hypertension Pipeline Outlook Key Takeaways from the Pulmonary Arterial Hypertension Pipeline Report In March 2025:- United Therapeutics conducted a study is to assess the effect of early and rapid treprostinil therapy for mean pulmonary artery pressure (mPAP) reduction to improve right ventricular (RV) function and reverse RV remodeling in participants with pulmonary arterial hypertension (PAH). In March 2025:- Actelion announced a study is to demonstrate superiority of macitentan 75 milligrams (mg) in prolonging the time to the first clinical events committee (CEC)-adjudicated morbidity or mortality (M/M) event in participants with symptomatic pulmonary arterial hypertension (PAH) compared to macitentan 10 mg. In March 2025: Merck Sharp & Dohme LLC announced a study are to evaluate the safety and tolerability, and pharmacokinetics (PK) of sotatercept over 24 weeks of treatment in children ≥1 to DelveInsight's Pulmonary Arterial Hypertension Pipeline analysis depicts a robust space with 55+ active players working to develop 55+ pipeline treatment therapies. The leading Pulmonary Arterial Hypertension Companies such as Merck Sharp & Dohme, Acceleron Pharma, Liquidia Technologies, Gossamer Bio, Resverlogix, PhaseBio Pharmaceuticals, Pharmosa BioPharm, Complexa, Gmax Biopharm Australia, Mezzion, Radikal Therapeutics, Galectin Therapeutics, Altavant Sciences, Ribomic and others. Promising Pulmonary Arterial Hypertension Therapies such as TPN171H, Tadalafil, Treprostinil Palmitil, Satralizumab (Genetical Recombination), PF-07868489, Sotatercept and others. Discover groundbreaking developments in Pulmonary Arterial Hypertension therapies! Gain in-depth knowledge of key Pulmonary Arterial Hypertension clinical trials, emerging drugs, and market opportunities @ Pulmonary Arterial Hypertension Clinical Trials Assessment Pulmonary Arterial Hypertension Emerging Drugs Profile Sotatercept: Acceleron Pharma Sotatercept is a first-in-class therapeutic fusion protein comprised of the extracellular domain of human activin receptor type IIA, fused to the Fc domain of human immunoglobulin G1 (IgG1). It provides balance of the growth-promoting activin growth differentiation factor pathway, and the growth-inhibiting BMP pathway by serving as a ligand trap for the TGF-β superfamily. The United States Food and Drug Administration (FDA) has granted Orphan Drug designation and Breakthrough Therapy designation to sotatercept for the treatment of PAH; the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to sotatercept for the treatment of PAH. Sotatercept is in Phase III clinical trial for the treatment of PAH. LIQ861: Liquidia Technologies LIQ861 is an investigational, inhaled dry powder formulation of treprostinil designed using the Company's novel PRINT technology and engineered with the goal of enhancing deep-lung delivery of treprostinil in PAH patients by means of a convenient, palm-sized dry powder inhaler. Liquidia resubmits New Drug Application for LIQ861 under the 505(b)(2) regulatory pathway for the treatment of pulmonary arterial hypertension (PAH). The Pulmonary Arterial Hypertension Pipeline report provides insights into The report provides detailed insights about companies that are developing therapies for the treatment of Pulmonary Arterial Hypertension with aggregate therapies developed by each company for the same. It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Pulmonary Arterial Hypertension Treatment. Pulmonary Arterial Hypertension Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects. Pulmonary Arterial Hypertension Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type. Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Pulmonary Arterial Hypertension market Stay informed about the Pulmonary Arterial Hypertension pipeline trends! Uncover critical updates on therapeutic innovations and their potential impact on patients and the healthcare industry @ Pulmonary Arterial Hypertension Unmet Needs Pulmonary Arterial Hypertension Companies Merck Sharp & Dohme, Acceleron Pharma, Liquidia Technologies, Gossamer Bio, Resverlogix, PhaseBio Pharmaceuticals, Pharmosa BioPharm, Complexa, Gmax Biopharm Australia, Mezzion, Radikal Therapeutics, Galectin Therapeutics, Altavant Sciences, Ribomic and others. Pulmonary Arterial Hypertension pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as Oral Parenteral Intravitreal Subretinal Topical Molecule Type Pulmonary Arterial Hypertension Products have been categorized under various Molecule types such as Monoclonal Antibody Peptides Polymer Small molecule Gene therapy Product Type Transform your understanding of the Pulmonary Arterial Hypertension Pipeline! See the latest progress in drug development and clinical research @ Pulmonary Arterial Hypertension Market Drivers and Barriers, and Future Perspectives Scope of the Pulmonary Arterial Hypertension Pipeline Report Coverage- Global Pulmonary Arterial Hypertension Companies- Merck Sharp & Dohme, Acceleron Pharma, Liquidia Technologies, Gossamer Bio, Resverlogix, PhaseBio Pharmaceuticals, Pharmosa BioPharm, Complexa, Gmax Biopharm Australia, Mezzion, Radikal Therapeutics, Galectin Therapeutics, Altavant Sciences, Ribomic and others. Pulmonary Arterial Hypertension Therapies- TPN171H, Tadalafil, Treprostinil Palmitil, Satralizumab (Genetical Recombination), PF-07868489, Sotatercept and others. Pulmonary Arterial Hypertension Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination Pulmonary Arterial Hypertension Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Stay Ahead in Oncology Research–Access the Full Pulmonary Arterial Hypertension Pipeline Analysis Today! @ Pulmonary Arterial Hypertension Drugs and Companies Table of Content Introduction Executive Summary Pulmonary Arterial Hypertension: Overview Pipeline Therapeutics Therapeutic Assessment Pulmonary Arterial Hypertension – DelveInsight's Analytical Perspective Late Stage Products (Phase III) Sotatercept: Acceleron Pharma Drug profiles in the detailed report….. Mid Stage Products (Phase II) GB-002: Gossamer Bio Drug profiles in the detailed report….. Early Stage Products (Phase I) Apabetalone: Resverlogix Drug profiles in the detailed report….. Preclinical/Discovery Stage Products R107: Radikal Therapeutics Drug profiles in the detailed report….. Inactive Products Pulmonary Arterial Hypertension Key Companies Pulmonary Arterial Hypertension Key Products Pulmonary Arterial Hypertension- Unmet Needs Pulmonary Arterial Hypertension- Market Drivers and Barriers Pulmonary Arterial Hypertension- Future Perspectives and Conclusion Pulmonary Arterial Hypertension Analyst Views Appendix About Us DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve. Media Contact Company Name: DelveInsight Business Research LLP Contact Person: Yash Bhardwaj Email: Send Email Phone: 09650213330 Address: 304 S. 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