Human prothrombin complex (Octapharma)

Critical Care Product Portfolio to be Highlighted During American Society of Anesthesiologists Medical Congress in San Francisco PARAMUS, N.J., Oct. 10, 2023 /PRNewswire/ -- Octapharma USA will sponsor the scientific symposium, Factor Concentrates for Perioperative Bleeding – Global Perspectives, Sunday, October 15th in conjunction with the American Society of Anesthesiologists (ASA) Annual Meeting in San Francisco. The symposium will address current gaps in research related to factor concentrates, including prothrombin complex concentrates (PCC) and fibrinogen concentrates (FC), for perioperative bleeding management. Continue Reading Perioperative coagulopathic bleeding is an important driver of morbidity & mortality in patients during major surgery. Tweet this Kamrouz Ghadimi, MD, MHSc, Department of Anesthesiology, Duke University, will discuss, "Perioperative Coagulopathic Bleeding – Definition, Treatment Algorithms, and POC Testing, Oh My!" Keyvan Karkouti, MD, Department of Anesthesiology, Toronto General Hospital, will discuss, "What's New in Research with PCC and Fibrinogen Concentrates in Surgery?" The presenters will review the role of PCC and FC in surgical patients and discuss best practices for bleeding management. As global practices in coagulation factor replacement for perioperative bleeding vary, the presenters will review recently published data, guidelines, ongoing studies, and strategies to help standardize bleeding management. The symposium will explore: The role of factor concentrates and blood products for management of bleeding in surgery; The latest research and current practice guidelines for factor concentrates in perioperative bleeding; and Individualized bleeding management strategies in cardiac surgery, with patient case presentations. "Perioperative coagulopathic bleeding is an important driver of morbidity and mortality in patients undergoing major surgery," said Dr. Ghadimi, one of the symposium presenters. "Over the past decade, the use of hemostasis algorithms that utilize factor concentrates has emerged as a key strategy to reduce transfusion burden in these patients." The educational breakfast symposium will be offered to ASA attendees October 15 at 6:30 am PST. To register, please visit connect.octapharmausa.com/events/asa23/index.html. "We look forward to presenting this important symposium in conjunction with the ASA Annual Meeting and connecting with the healthcare community to advance critical care medicine," said Octapharma USA President Flemming Nielsen. "Octapharma is committed to providing patients with life-saving and life-enhancing therapies for critical care medicine. Our team will be on hand during ASA to share the latest developments in the Octapharma critical care product portfolio." In July, Octapharma received U.S. Food and Drug Administration (FDA) approval for Balfaxar® (prothrombin complex concentrate, human-lans; marketed in Europe and Canada as octaplex®) for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with need for urgent surgery or invasive procedures. The Octapharma USA critical care portfolio also includes fibryga®, Fibrinogen (Human) Lyophilized Powder for Reconstitution, a therapy indicated for the treatment of acute bleeding episodes in adults and children with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. The Octapharma critical care booth (#461) at ASA will provide attendees with information on the full product portfolio. The ASA Annual Meeting will be held October 13 – 17 at San Francisco's Moscone Center. For more information, please visit asahq.org/annualmeeting. About Balfaxar® Balfaxar® (prothrombin complex concentrate, human-lans) is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with need for an urgent surgery/invasive procedure. WARNING: ARTERIAL and VENOUS THROMBOEMBOLIC COMPLICATIONS Patients being treated with Vitamin K antagonists (VKA) therapy have underlying disease states that predispose them to thromboembolic events. Potential benefits of reversing VKA should be weighed against the potential risks of thromboembolic events, especially in patients with the history of a thromboembolic event. Resumption of anticoagulation should be carefully considered as soon as the risk of thromboembolic events outweighs the risk of acute bleeding. Both fatal and non-fatal arterial and venous thromboembolic complications have been reported with Balfaxar® in clinical trials and post marketing surveillance. Monitor patients receiving Balfaxar® for signs and symptoms of thromboembolic events. Balfaxar® may not be suitable in patients with thromboembolic events in the prior 3 months. For complete boxed warning and full prescribing information, please visit Balfaxar.com. About fibryga ® Fibryga®, Fibrinogen (Human) Lyophilized Powder for Reconstitution, for Intravenous Use, is a human fibrinogen concentrate indicated for the treatment of acute bleeding episodes in adults and children with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. Fibryga® is not indicated for dysfibrinogenemia. Contraindications Fibryga® is contraindicated in individuals who have manifested severe immediate hypersensitivity reactions, including anaphylaxis, to fibryga® or its components. Warnings and Precautions Monitor patients for early signs of hypersensitivity or allergic reactions. If necessary, discontinue administration and institute appropriate treatment. Thrombotic events have been reported in patients receiving fibryga®. Treatment with human fibrinogen concentrate has been associated with thrombosis at target plasma fibrinogen levels that were below 150 mg/dL. The thrombotic risks may be greater when the target fibrinogen plasma level is 150 mg/dL. Weigh the benefits of administration versus the risks of thrombosis. Fibryga® is made from pooled human plasma. Products made from human plasma may contain infectious agents, e.g., viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. Adverse Events The most serious adverse reactions that may be observed with fibryga® are thromboembolic episodes and anaphylactic type reactions. The most common adverse reactions observed in more than one subject in clinical studies with fibryga® (>5% of subjects) were nausea, vomiting, pyrexia (fever) and thrombocytosis. For complete prescribing information, please visit fibrygausa.com/pi. About the Octapharma Group Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. Octapharma employs more than 11,000 people worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Hematology, Immunotherapy and Critical Care. Octapharma has seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany and Sweden, and operates more than 190 plasma donation centers across Europe and the US. The company's American subsidiary, Octapharma USA, is located in Paramus, N.J. For more information, please visit octapharmausa.com. BALF-0111-PPR SOURCE Octapharma

For the second time this year, the FDA has approved a non-prescription naloxone nasal spray to counteract the effects of opioid overdose. The latest regulatory decision is for a product from Harm Reduction Therapeutics. Harm Reduction, a nonprofit pharmaceutical company founded in 2017, claims that not having a profit motive allows it to focus on its mission of saving lives by making OTC naloxone available for free or at the lowest possible cost. The FDA approval now clears the way for Pittsburgh-based Harm Reduction to launch its product, which will be marketed under the name RiVive. The FDA decision for RiVive is based on data from a study that showed the nasal spray achieves similar levels in the blood as an approved prescription naloxone product. Harm Reduction also provided data showing consumers understand how to use the drug safely and effectively without guidance from a clinician. According to the FDA, more than 105,000 reported fatal overdoses occurred in the 12-month period ending in February 2023. These overdoses were primarily driven by synthetic opioids like illicit fentanyl, the agency said. “We know naloxone is a powerful tool to help quickly reverse the effects of opioids during an overdose. Ensuring naloxone is widely available, especially as an approved OTC product, makes a critical tool available to help protect public health,” FDA Commissioner Robert Califf said in the regulator’s announcement. “The agency has long prioritized access to naloxone products, and we welcome manufacturers of other naloxone products to discuss potential nonprescription development programs with the FDA.” RiVive’s approval comes four months after the FDA approved an OTC version of Narcan from Emergent BioSolutions, making that product the first nasal spray naloxone product available without a prescription. Emergent said at the time it expected OTC Narcan would become available by late summer. It’s been a busy week for regulatory developments in the U.S. and Europe. Here’s a recap of some recent regulatory news highlights: —Biohaven received an FDA refuse to file letter for troriluzole, an experimental treatment for spinocerebellar ataxia (SCA), a rare neuromuscular disorder with no approved therapies. The drug failed its Phase 3 study but a post hoc analysis showed more encouraging results in a subset of patients. Biohaven had sought approval for treating this subset of SCA patients. The FDA declined to review the application. Biohaven said it will request a meeting to discuss the FDA’s concerns. —Octapharma’s Balfaxar, a drug that reverses the effects of the blood thinner warfarin, is now FDA approved for treating patients undergoing surgical procedures. But clinical trial results showed more complications and deaths in the study drug group versus the comparator arm. Balfaxar’s approval comes with a black box warning and a post-marketing requirement for a clinical trial to further assess the drug’s risks. —Gilead Sciences drug Trodelvy is now approved in Europe for treating breast cancer in patients whose disease is classified as HR positive and HER2 negative, which is the most common type of breast cancer. The European Commission decision covers patients who have received endocrine-based therapy and at least two additional systemic therapies. The FDA approved Trodelvy for this indication in February. —AstraZeneca drug Soliris, whose approved indications include the rare neuromuscular disorder generalized myasthenia gravis (gMG), is now approved in Europe for treating that disorder in children and adolescents. The antibody drug, developed by AstraZeneca rare disease subsidiary Alexion, is designed to block C5, a complement system protein whose excessive activity is associated with some autoimmune disorders. —A drug that initially reached the market for controlling fleas and ticks in dogs and cats is now approved for treating Demodex blepharitis, an inflammatory eye condition in humans that’s caused by infestation of mites. The Tarsus Pharmaceuticals drug is an eye drop formulation of the oral veterinary product lotilaner. Tarsus will market its new drug under the brand name Xdemvy. FDA approval of the drug for Demodex blepharitis makes it the first drug authorized for the eye indication. —Mirum Pharmaceuticals drug Livmarli is now approved in Canada. The drug was developed to treat the severe itching symptom associated with the rare liver disease Alagille syndrome. The FDA approved Livmarli for treating Alagille syndrome patients in 2021. —An anthrax vaccine developed by Emergent BioSolutions received FDA approval. Cyfendus was developed to prevent anthrax disease in adults 18 to 65 who have been exposed to the pathogen. The two-dose intramuscular injection is given alongside antibacterial drugs. Emergent developed Cyfendus in partnership with the Biomedical Advanced Research and Development Authority. The vaccine joins an Emergent anthrax portfolio that includes the BioThrax vaccine and two treatments, Anthrasil and raxibacumab. —Daiichi Sankyo cancer drug Vanflyta received FDA approval for treating acute myeloid leukemia (AML) in combination with chemotherapies. The approval also includes use of the drug as a maintenance monotherapy following consolidation chemotherapy. Vanflyta specifically treats AML patients whose disease exhibits FLT3-ITD mutations. The FDA also approved a companion diagnostic to identify this mutation in newly diagnosed AML patients. —The European Medicines Agency’s Committee for Medicinal Products for Human Use issued a negative opinion on Krazati, a Mirati Therapeutics drug for advanced non-small cell cancer that carries a mutation called KRAS G12C. According to the company, the committee said the drug has a positive risk-benefit profile, but it does not fulfill certain requirements for a conditional marketing authorization. Mirati said it disagrees with the opinion and will request a re-examination. Krazati received accelerated FDA approval last year.