Ventricular Premature Complexes

SHIRLEY, N.Y., Oct. 29, 2024 /PRNewswire/ -- American Regent announces the launch of 30 mL Epinephrine Injection, USP.1 Epinephrine Injection, USP is indicated for emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from insect stings or bites, foods, drugs, sera, diagnostic testing substances, and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. Epinephrine is also indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. Continue Reading Epinephrine Injection, USP is supplied as a 30 mg/30 mL (1 mg/mL) multiple-dose vial in a shelf pack of one. "With the approval of Epinephrine Injection, USP we continue to show our commitment to ensuring both patients and providers have access to high-quality treatment options," stated Joann Gioia, Vice President and Chief Commercial Officer at American Regent, Inc. Product is available for immediate shipment. Customers can order Epinephrine Injection, USP through their wholesaler/distributor or by contacting our Customer Support Group at 1-800-645-1706. Epinephrine Injection, USP is supplied as follows: Please see the accompanying Important Safety Information in addition to the Full Prescribing Information. For additional information, please visit americanregent.com. REFERENCE: 1. Epinephrine Injection, USP. Package insert. American Regent, Inc. © 2024 American Regent, Inc. All rights reserved. PP-EP-US-0024 5 Ramsey Road, Shirley, NY 11747 \\ 1.800.645.1706 F 631.924.1731 \\ A Daiichi Sankyo Group Company Epinephrine Injection, USP 30 mL For intramuscular, subcutaneous, and intravenous use. INDICATIONS AND USAGE Anaphylaxis Emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from insect stings or bites, foods, drugs, sera, diagnostic testing substances, and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. Hypotension associated with Septic Shock To increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS: None. WARNINGS AND PRECAUTIONS Incorrect Locations of Injection for Anaphylaxis: Injection into the anterolateral aspect of the thigh (vastus lateralis muscle) is the most appropriate location for administration because of its location, size, and available blood flow. Injection into (or near) smaller muscles, such as in the deltoid, is not recommended. Do not administer repeated injections of epinephrine at the same site, as the resulting vasoconstriction may cause tissue necrosis. Do not inject into buttock, digits, hands, or feet. Serious Infections at the Injection Site: Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported. Extravasation and Tissue Necrosis with Intravenous Infusion: Avoid extravasation into tissues, which can cause local necrosis. When epinephrine is administered intravenously, check the infusion site frequently. Hypertension: Because individual response to epinephrine may vary significantly, monitor blood pressure frequently and titrate to avoid excessive increases in blood pressure. Patients receiving monoamine oxidase inhibitors or antidepressants of the triptyline or imipramine types may experience severe, prolonged hypertension. Pulmonary Edema: Epinephrine increases cardiac output and causes peripheral vasoconstriction, which may result in pulmonary edema. Renal Impairment: Epinephrine constricts renal blood vessels, which may result in oliguria or renal impairment. Cardiac Arrhythmias and Ischemia: Epinephrine may induce cardiac arrhythmias and myocardial ischemia, especially in patients suffering from coronary artery disease or cardiomyopathy. May aggravate angina pectoris or produce ventricular arrhythmias. Allergic Reactions Associated with Sulfite: The Epinephrine 30 mL multiple-dose vial contains sodium metabisulfite, which may cause mild to severe allergic reactions including anaphylaxis or asthmatic episodes in susceptible individuals. ADVERSE REACTIONS Common adverse reactions to systemically administered epinephrine include, but are not limited to, anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and respiratory difficulties. These symptoms occur in some persons receiving therapeutic doses of epinephrine, but are more likely to occur in patients with heart disease, hypertension, or hyperthyroidism. The true incidence of adverse reactions associated with the systemic use of epinephrine is difficult to determine. Adverse reactions reported in observational trials, case reports, and studies are listed below by body system: Cardiovascular: Angina, arrhythmias, hypertension, pallor, palpitations, tachyarrhythmia, tachycardia, vasoconstriction, ventricular ectopy, and stress cardiomyopathy. Rapid rises in blood pressure associated with epinephrine use have produced cerebral hemorrhage, particularly in elderly patients with cardiovascular disease. Neurological: Disorientation, impaired memory, panic, psychomotor agitation, sleepiness, tingling. Psychiatric: Anxiety, apprehensiveness, restlessness. Other: Patients with Parkinson's disease may experience psychomotor agitation or a temporary worsening of symptoms. Diabetic patients may experience transient increases in blood sugar. Injection into the buttock has resulted in cases of gas gangrene. Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported following epinephrine injection in the thigh. USE IN SPECIFIC POPULATIONS Elderly patients and pregnant women may be at greater risk of developing adverse reactions when epinephrine is administered parenterally. Pregnancy May cause fetal harm. Labor or Delivery: There are risks to the mother and fetus associated with epinephrine use during labor or delivery. Epinephrine usually inhibits spontaneous or oxytocin-induced contractions of the pregnant human uterus and may delay the second stage of labor. Avoid epinephrine during the second stage of labor. Although epinephrine may improve maternal hypotension associated with septic shock and anaphylaxis, it may result in uterine vasoconstriction, decreased uterine blood flow, and fetal anoxia. Lactation There is no information regarding the presence of epinephrine in human milk or the effects of epinephrine on the breastfed infant or on milk production. Pediatric Use Reported clinical experience with the use of epinephrine suggests that the adverse reactions seen in children are similar in nature and extent to those both expected and reported in adults. Safety and effectiveness of epinephrine in pediatric patients with septic shock have not been established. Geriatric Use In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. OVERDOSAGE Overdosage of epinephrine may produce extremely elevated arterial pressure, which may result in cerebrovascular hemorrhage, particularly in elderly patients. Overdosage may also result in pulmonary edema, transient bradycardia followed by tachycardia, and these may be accompanied by potentially fatal cardiac arrhythmias. Subsidence of the ventricular effects may be followed by atrial tachycardia and occasionally by atrioventricular block. Myocardial ischemia and infarction, cardiomyopathy, extreme pallor and coldness of the skin, metabolic acidosis due to elevated blood lactic acid levels, and renal insufficiency have also been reported. For additional Safety Information, please see the Full Prescribing Information. REF-2454 4/2023 You are encouraged to report adverse drug events (ADEs) to American Regent®: T 1.800.734.9236; E [email protected]; F 1.610.650.0170 ADEs may also be reported to the FDA: 1.800.FDA.1088 or Medical information: T 1.888.354.4855 (9:00 am–5:00 pm Eastern Time, Monday–Friday) medical information outside of normal business hours that cannot wait until the next business day, please call 1.877.845.6371 About American Regent For more than 50 years, American Regent has been developing, manufacturing, and supplying quality generic and branded injectables. For more than 20 years, we have been a leader in IV iron therapy. We are committed to setting a higher standard for responsiveness and reliability as a US-based manufacturer. To ensure that we deliver on our mission to improve human and animal health, we continue to make investments in expanding and modernizing our manufacturing facilities in Ohio and New York and have expanded our footprint into California. This growth will increase our capacity, create redundancies across our manufacturing sites, and strengthen our expertise in the development of complex drug products and delivery systems. What that means for you is a partner committed to delivering essential medications now and in the future. For more information, please visit . About Daiichi Sankyo Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops, and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular, and other diseases with high unmet medical needs. For more information, please visit . SOURCE American Regent, Inc. 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First and only contact force pulsed field ablation (PFA) system designed to transform treatment for millions with life-threatening ventricular arrhythmias.Preliminary data of VCAS study will be presented at HRS 2024 in Boston, Mass.CARDIFF-BY-THE-SEA, Calif., May 9, 2024 /PRNewswire/ -- Field Medical,™ Inc., a pioneer in pulsed field cardiac catheter ablation technology, today announced the initiation of its first-in-human study for the FieldForce™ Ablation System at Na Homolce Hospital in Prague, Czech Republic. The Ventricular Catheter Ablation Study, VCAS, will enroll up to 60 patients at up to 5 sites world-wide. The VCAS investigational study is a critical step towards demonstrating safety and performance of the FieldForce™ Ablation System, developed specifically to address the limitations of existing pulsed field ablation (PFA) and radiofrequency (RF) ablation systems, including a more time efficient treatment protocol for the treatment of ventricular arrhythmias. Preliminary results will be presented on May 16, 2024, at the Heart Rhythm Scientific Sessions in Boston, Mass. Continue Reading Field Medical’s FieldForce™ Catheter tip (A). The FieldBending™ technology utilizes an innovative internalized electrode within a fluid lumen seen in the cutaway (B). Voltage is delivered between the external and internal electrodes resulting in desirable electric field characteristics. The FieldForce™ Catheter is the first and only contact force PFA catheter optimized for the ventricles. "The FieldForce Ablation System, as the first contact force PFA system for ventricular ablation, is demonstrating significant promise early in our trials," said Vivek Reddy, MD, Director of Electrophysiology for the Mount Sinai Health System. "This is my first experience with a technology capable of achieving rapid complete transmural left ventricular (LV) ablation, offering highly targeted treatment options and an efficient workflow. Although these results are quite preliminary, the potential of this system to revolutionize catheter ablation of complex ventricular arrhythmias is profound, potentially surpassing the current standard of care. The scientific community will benefit from the comprehensive results from the completed study." PFA Adoption and Transition from Atrial to Ventricular Arrhythmias PFA has revolutionized the treatment of atrial fibrillation (AF) over the past decade, thanks to pioneering work by Field Medical CEO Steven Mickelsen, MD, founder of Farapulse which was subsequently acquired by Boston Scientific. His development of PFA technology marked a significant shift in cardiac electrophysiology, enhancing safety and reducing procedure times. This innovation set a new standard in the industry, leading to widespread adoption and the transformation of ablation practices. With PFA's proven success in atrial settings, Field Medical is now poised to extend these benefits to ventricular arrhythmias, signaling a pivotal evolution in the management of complex ventricular cardiac conditions. Ventricular Arrhythmia Burden It is estimated that ventricular arrhythmia impact over 6 million patients in the US and Europe. Ventricular arrhythmias, including ventricular tachycardia (VT) and premature ventricular contractions (PVCs), and pose a substantial risk, often leading to sudden cardiac death if not adequately managed. Current ventricular catheter ablation methods involve lengthy procedures and significant risks associated with thermal ablation, like conventional RF ablation. Field Medical's PFA technology aims to address these challenges by providing the first and only contact force PFA catheter optimized to work in the ventricle. This novel technology may enable predictable, time efficient, and safe treatment option. FieldBending™ takes advantage of non-intuitive physics to deliver intense, yet brief, electric fields designed to safely reduce procedure times dramatically."Our vision at Field Medical is to transform VT ablation into a widely available, one-hour outpatient procedure with improved safety outcomes," said Steven Mickelsen MD, CEO of Field Medical. "With the promising early data for our VCAS study, in much the same way that PFA transformed AF, the FieldForce Ablation System is optimized to transform how ventricular arrhythmias are treated, offering hope to millions of patients worldwide. With the strong investor support, renown physician engagement and the groundbreaking potential of our technology, we are set to redefine the standards of cardiac ablation once again." About VCAS Study Field Medical's VCAS Study is a pivotal segment of a prospective safety and feasibility study, assessing the innovative FieldForce Ablation System in patients with ventricular arrhythmias. The VCAS-I group focuses on individuals suffering from ventricular tachycardia (VT), while the VCAS-II group targets those experiencing frequent premature ventricular complexes (PVCs). This study is instrumental in evaluating the performance of Pulsed Field Ablation (PFA), thereby potentially reducing procedural time compared to traditional Radiofrequency (RF) ablation. The trial aims to demonstrate that PFA can safely treat and improve overall outcomes for patients with challenging ventricular arrhythmias. For study information, visit clinicaltrials.gov NCT: NCT06203262. About Field Medical,™ Inc . Founded in 2022, Field Medical is at the forefront of developing second-generation pulsed field ablation (PFA) technologies, designed to meet the technical and safety challenges of modern cardiac ablation procedures. Under the leadership of Dr. Steven Mickelsen, CEO, a globally recognized expert in pulsed electric field technology, the company has pioneered the proprietary FieldBending™ technology. This innovation was developed to concentrate therapeutic effects and reduce unwanted far-field effects, with the potential to improve patient outcomes while simplifying the clinical experience for physicians. Field Medical focuses on expanding the applications of PFA beyond atrial fibrillation (AF) to address complex ventricular arrhythmias—a condition affecting over 6 million people in North America and Europe alone, often leading to sudden cardiac death, heart failure and significant clinical symptoms if not managed effectively. The company's comprehensive product portfolio, including the FieldForce™ Catheter, FieldForce™ Ablation System, and the FieldFlex™ Sheath, is specifically optimized to work in complex ventricular environments. For more information, visit and follow us on LinkedIn and X.The FieldForce™ PFA Ablation System is an investigational device and is limited by Federal (or United States) Law to investigational use. SOURCE Field Medical, Inc.

PKP2 Mutations Are the Leading Cause of ARVC, a Dangerous Condition Linked to Sudden Cardiac Arrest in Young People Estimated to Affect 70,000 People in the US TN-401 Preclinical Studies Demonstrated Robust Reduction of Ventricular Arrhythmias and Extended Survival in Knockout Models of Disease After a Single Dose SOUTH SAN FRANCISCO, Calif., Oct. 26, 2023 (GLOBE NEWSWIRE) -- Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, announced today that the U.S. Food and Drug Administration (FDA) has provided clearance of the company’s Investigational New Drug (IND) application to initiate clinical testing of TN-401. TN-401 is Tenaya’s adeno-associated virus serotype 9 (AAV9)-based investigational gene therapy product candidate for the treatment of arrhythmogenic right ventricular cardiomyopathy (ARVC) caused by mutations in the plakophilin-2 (PKP2) gene. Based on this IND clearance, the company plans to initiate the RIDGE-1™ Phase 1b clinical trial of TN-401, a multi-center, open-label study to assess the safety, tolerability and clinical efficacy of a one-time intravenous infusion of TN-401. Tenaya is currently conducting the RIDGE™ global non-interventional natural history and serotype study of PKP2-associated ARVC. ARVC, also known as arrhythmogenic cardiomyopathy (ACM), is a chronic, progressive, familial disease that typically presents before age 40. People with ARVC experience symptoms related to ventricular arrhythmias, including palpitations, lightheadedness and fainting, and are at increased risk of sudden cardiac death. PKP2 mutations are the most common genetic cause of ARVC and result in a loss of key proteins needed to maintain the structural integrity and cell-to-cell signaling of heart muscle cells. TN-401 is designed to address the underlying cause of disease by delivering a fully functional PKP2 gene to restore normal PKP2 protein levels and thereby slow disease progression and reverse the course of disease after a single dose. “People with arrhythmogenic cardiomyopathy report high levels of fear and stress and must withstand burdensome physical and lifestyle restrictions in an effort to manage the frequent abnormal heart rhythms and constant risk of sudden cardiac arrest associated with their disease,” said Whit Tingley, M.D., Ph.D., Tenaya’s Chief Medical Officer. “TN-401 is intended to address the genetic mutation most frequently underlying ARVC. The initial dose for TN-401 in the RIDGE-1 study was associated with near maximal efficacy in our preclinical studies. With clinical site and patient community engagement well underway, we look forward to rapidly advancing TN-401 into the clinic.” In preclinical studies in a knock-out mouse model of disease, Tenaya’s PKP2 gene therapy administered at a dose of 3E13 vg/kg restored normal levels of PKP2 protein expression and demonstrated durable efficacy in preventing disease development and slowing or reversing disease progression after onset leading to long-term survival. AAV9 was selected as the vector for delivery of Tenaya’s PKP2 gene therapy based on its extensive clinical and commercial safety record in thousands of patients globally and its demonstrated ability in clinical studies to broadly distribute around the human heart and robustly express in heart muscle cells. Tenaya has completed cGMP drug product manufacturing at the 1000-liter scale for TN-401 at the company’s Genetic Medicines Manufacturing Center, with sufficient drug product produced to support the entire Phase 1b study. TN-401 RIDGE-1 Phase 1b Protocol Tenaya’s RIDGE-1 Phase 1b clinical trial of TN-401 is a multi-center, open-label study to assess the safety, tolerability and clinical efficacy of a one-time intravenous infusion of TN-401. The RIDGE-1 clinical trial will seek to enroll up to fifteen adults who have been diagnosed with PKP2-associated ARVC. Trial participants must have an implantable cardioverter defibrillator (ICD) and be at increased risk for arrhythmias as determined during screening by premature ventricular contraction (PVC) count. The trial will be conducted in two stages, with dose administration and outpatient assessments through 52-weeks and a long-term follow-up segment for four-years thereafter. Enrollment will be divided into two dose cohorts, starting at a dose of 3E13 vg/kg, a dose associated with near-maximal efficacy in preclinical studies. Following dosing of the first three patients, a panel of independent safety reviewers will advise on plans to dose escalate and expand enrollment of the initial cohort. The trial protocol includes assessments of safety, markers of cardiac transduction and transgene expression in right ventricular biopsy samples, changes in PVC, sustained or non-sustained ventricular tachycardia (VT or NSVT) occurrences, circulating plasma biomarkers, imaging biomarkers of disease as measured by echocardiogram and patient-reported outcomes. About PKP2-Associated ARVC Plakophilin-2 (PKP2) mutations are the most common genetic cause of arrhythmogenic right ventricular cardiomyopathy (ARVC), estimated to represent approximately 40 percent of the overall ARVC population. The prevalence of PKP2-associated ARVC is estimated at more than 70,000 people in the U.S. alone, though it frequently goes undiagnosed as sudden cardiac death is the first sign of disease in nearly one quarter of known cases. In PKP2-associated ARVC, mutations of the PKP2 gene results in insufficient expression of a protein needed for the proper functioning of the desmosomal complex that maintains physical connections and electrical signaling between heart muscle cells. As the desmosome structure degrades, cardiac muscle cells are replaced by fibrofatty tissue and electrical pulses in the heart become unstable, resulting in adverse remodeling and irregular heart rhythms. ARVC symptoms include arrhythmias, palpitations, lightheadedness, dizziness and fainting. It is typically diagnosed before age 40, and sudden cardiac arrest due to life-threatening ventricular arrhythmias is frequently the first manifestation of disease. Current treatments include anti-arrhythmic medications, implantable cardioverter-defibrillators (ICDs) and ablation procedures, which do not address the underlying genetic cause of disease. About TN-401 Gene Therapy and the RIDGE Clinical Program TN-401 is an investigational adeno-associated virus serotype 9 (AAV9)-based gene therapy being developed for the treatment of ARVC due to disease causing variants in the PKP2 gene. AAV9 was selected as the vector for delivery of Tenaya’s PKP2 gene therapy based on its extensive clinical and commercial safety record and demonstrated ability to target heart muscle cells. In preclinical studies, Tenaya has shown that a single dose of TN-401 restored normal levels of PKP2, normalized heart rhythms, improved right and left ventricular size and function and extended survival. Tenaya has received clearance from the FDA to initiate its first-in-human RIDGE-1TM Phase 1b clinical trial of TN-401 in patients with PKP2-associated ARVC. To support TN-401’s clinical development, the company is currently enrolling the RIDGETM global non-interventional study to collect natural history and AAV9 antibody (seroprevalence) data among PKP2 gene mutation carriers with ARVC. TN-401 has received Orphan Drug Designation from the FDA. About Tenaya Therapeutics Tenaya Therapeutics is a clinical-stage biotechnology company committed to a bold mission: to discover, develop and deliver potentially curative therapies that address the underlying drivers of heart disease. Leveraging its integrated and interrelated Gene Therapy, Cellular Regeneration and Precision Medicine platforms and proprietary core capabilities, the company is advancing a pipeline of novel therapies with diverse treatment modalities for rare genetic cardiovascular disorders and more prevalent heart conditions. Tenaya’s most advanced candidates include TN-201, a gene therapy for MYBPC3-associated hypertrophic cardiomyopathy (HCM), TN-401, a gene therapy for PKP2-associated arrhythmogenic right ventricular cardiomyopathy (ARVC), and TN-301, a small molecule HDAC6 inhibitor being initially developed for heart failure with preserved ejection fraction (HFpEF). Tenaya also has multiple early-stage programs progressing through preclinical development. For more information, visit . Forward-looking Statement This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Words such as “plans,” “look forward,” “will,” and similar expressions are intended to identify forward-looking statements. Such forward-looking statements include, among other things, the plan to rapidly initiate RIDGE-1, a Phase 1b clinical trial of TN-401; the clinical and therapeutic potential of TN-401 as a treatment to address the genetic mutation most frequently underlying ARVC; enrollment targets for RIDGE-1; and clinical development plans for TN-401 and statements by Tenaya’s Chief Medical Officer. The forward-looking statements contained herein are based upon Tenaya’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. These forward-looking statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, including but not limited to: the impact of any future communications from the FDA regarding Tenaya’s TN-401 IND; the costs of conducting clinical trials; Tenaya’s ability to execute on its clinical development plans for TN-401; the potential failure of TN-401 to demonstrate safety and/or efficacy in clinical testing; the potential for RIDGE-1 initial clinical trial results to differ from preclinical or expected results; the timing, scope and likelihood of regulatory filings and approvals for TN-401; Tenaya’s ability to successfully operate a manufacturing facility for clinical supply for TN-401; risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and operating as an early stage company; Tenaya’s ability to develop, initiate or complete preclinical studies and clinical trials, and obtain approvals, for any of its product candidates; Tenaya’s continuing compliance with applicable legal and regulatory requirements; Tenaya’s ability to raise any additional funding it will need to continue to pursue its business and product development plans; Tenaya’s reliance on third parties; Tenaya’s commercialization and marketing capabilities and strategy; the loss of key scientific or management personnel; competition in the industry in which Tenaya operates; Tenaya’s ability to obtain and maintain intellectual property protection for its product candidates; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in documents that Tenaya files from time to time with the Securities and Exchange Commission. These forward-looking statements are made as of the date of this press release, and Tenaya assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Contacts Michelle Corral VP, Corporate Communications and Investor Relations IR@tenayathera.com Investors Julie Seidel Stern Investor Relations Julie.seidel@SternIR.com Media Wendy Ryan Ten Bridge Communications wendy@tenbridgecommunications.com