Latest news with #AdverseEventReportingSystem
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
Yahoo
27-03-2025
- Health
- Yahoo
Senate Republican questions FDA chief on counterfeit weight loss drugs
Sen. Jim Banks (R-Ind.) wants the Food and Drug Administration (FDA) to look into foreign-made active pharmaceutical ingredients he says are being included in online weight loss drugs. In a letter to acting FDA Commissioner Sara Brenner, Banks warned that the nation is seeing a spike in drugs with the foreign-made ingredients that could post health risks for Americans purchasing them online. 'Booming online gray and black markets are flooding the country with knock-off and counterfeit GLP-1s contaminated with foreign-made APIs [active pharmaceutical ingredients], and few Americans purchasing these drugs are aware of the risks they pose,' Banks wrote in the Wednesday letter. 'I request detailed information about how the Food and Drug Administration (FDA) will prevent unlawful APIs from entering the country and potentially harming Americans,' he added. GLP-1s refer to compounded glucagon-like peptide 1 agonist medications — injectable weight-loss drugs. Banks in the letter said the FDA's Adverse Event Reporting System database at the end of last year had recorded more than 900 cases of adverse health events associated with the matter, which he said was four times the number seen in fiscal 2022. Seventeen of those cases involved deaths, Banks wrote. Banks wrote that faulty medications were entering the country due to a lack of FDA assessment at points of entry. 'These drugs come in formulations that the FDA has never approved, have inconsistent doses, misrepresent injectable insulin as semaglutide, contain contaminants, or are in reality completely different drugs,' the Indiana senator said. Those selling such drugs must be shut down he added. Banks's letter to Brenner asks how the FDA will work with U.S. Customs and Border Protection to prevent counterfeit drugs from entering the United States while educating communities about the difference between authentic and knockoff drugs. The Hill has reached out to the FDA for comment. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
The Hill
27-03-2025
- Health
- The Hill
Senate Republican questions FDA chief on counterfeit weight loss drugs
Sen. Jim Banks (R-Ind.) wants the Food and Drug Administration to look into foreign-made active pharmaceutical ingredients he says are being included online weight loss drugs. In a letter to acting FDA Commissioner Sara Brenner, Banks warned that the nation is seeing a spike in drugs with the foreign-made ingredients that could post health risks for Americans purchasing them online. 'Booming online gray and black markets are flooding the country with knock-off and counterfeit GLP-1s contaminated with foreign-made APIs [active pharmaceutical ingredients], and few Americans purchasing these drugs are aware of the risks they pose,' Banks wrote in th Wednesday letter. 'I request detailed information about how the Food and Drug Administration (FDA) will prevent unlawful APIs from entering the country and potentially harming Americans,' he added. GLP-1s refers to compounded glucagon-like peptide 1 agonist medications — injectable weight-loss drugs. Banks in the letter said the FDA's Adverse Event Reporting System database as of the end of last year had recorded more than 900 cases of adverse health events associated with the matter, which he said was four times the number see in the 2022 fiscal year. Seventeen of those cases involved deaths, Banks wrote. Banks wrote that faulty medications were enters the country because of a lack of FDA assessment at points of entry. 'These drugs come in formulations that the FDA has never approved, have inconsistent doses, misrepresent injectable insulin as semaglutide, contain contaminants, or are in reality completely different drugs,' the Indiana senator said. Those selling such drugs must be shut down, he added. Banks's letter to Brenner asks how the FDA will work with U.S. Customs and Border Protection to prevent counterfeit drugs from entering the United States while educating communities about the difference between authentic and knock off drugs.
