European Authorities Approve Lyophilized S/D Treated Plasma OctaplasLG® for Pre-Hospital Transfusion
Octapharma AG today announced that European medical authorities have approved the lyophilised presentation of the well-established octaplasLG® - pharmaceutically-licensed S/D treated plasma for transfusion. The line extension, which will be marketed in Europe as a powder and solvent for solution for infusion, offers new and potentially life-saving treatment options in pre-hospital and emergency settings.
“The European authorization of octaplasLG® powder continues Octapharma's ongoing commitment to help prevent uncontrolled haemorrhage associated with trauma, which accounts for 30%-50% of all deaths in the first 24 hours"1-5, says Dr. Oliver Hegener, Vice President IBU Critical Care.
Trauma results in 4.4 million deaths worldwide annually6, with uncontrolled bleeding being the major cause of potentially preventable death. Trauma-induced coagulopathy (TIC) is an early abnormal response characterised by hypocoagulation, in addition to acute blood loss, shock, hypothermia and metabolic acidosis, that begins soon after injury. Early - pre-hospital - administration of plasma has been shown to increase survival, compared with crystalloids, when pre-hospital transport was longer than 20 minutes.7
Until now, access to early plasma transfusion was limited by logistic hurdles as well as a lack of available transfusion medicine in the pre-hospital setting for both for civilian and military patients.
"octaplasLG® powder, an AB universal plasma, can be stored at room temperature and reconstituted within minutes, representing a potentially lifesaving treatment option in emergency situations and in locations with limited frozen storage facilities and cold chain infrastructure required for regular FFP," explains Dr. Hegener.
About octaplasLG®
Pharmaceutical grade human plasma for infusion with standardised quality and unique pathogen safety profiles due to Octapharma’s integrated pathogen elimination/inactivation concept. The standardised content is achieved by pooling between 630 and 1520 single plasma units from multiple carefully screened donors. Safety measures present during manufacturing include: Donor screening, immunoneutralisation, Solvent/detergent treatment and Ligand affinity chromatography for prion reduction.
The product is approved for:
- Complex deficiencies of coagulation factors such as coagulopathy due to severe hepatic failure or massive transfusion.
- Substitution therapy in coagulation factor deficiencies, when a specific coagulation factor concentrate (e.g., factor V or factor XI) is not available for use or in emergency situations when a precise laboratory diagnosis is not possible.
- Rapid reversal of the effects of oral anticoagulants (coumarin or indanedione type) when a prothrombin complex concentrate is not available for use or administration of vitamin K is insufficient due to impaired liver function or in emergency situations.
- Potentially dangerous haemorrhages during fibrinolytic therapy, using e.g., tissue plasminogen activators, in patients who fail to respond to conventional measures.
- Therapeutic plasma exchange procedures, including those in thrombotic thrombocytopenic purpura (TTP).
About Octapharma
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: Immunotherapy, Haematology, 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 centres across Europe and the US.
References:
1. Bosch F, Angele MK, Chaudry IH. Gender differences in trauma, shock and sepsis. Mil Med Res. 2018;5(1):35.
2. Iapichino GE, Ponschab M, Cadamuro J, et al. Concentrated lyophilized plasma used for reconstitution of whole blood leads to higher coagulation factor activity, but unchanged thrombin potential compared with fresh-frozen plasma. Transfusion. 2017;57(7):1763-71.
3. Nguyen C, Bordes J, Cungi PJ, et al. Use of French lyophilized plasma transfusion in severe trauma patients is associated with an early plasma transfusion and early transfusion ratio improvement. J Trauma Acute Care Surg. 2018;84(5):780-5.
4. Moore EE, Moore HB, Kornblith LZ, et al. Trauma-induced coagulopathy. Nat Rev Dis Primers. 2021;7(1):30.
5. Johansson PI, Sorensen AM, Perner A, et al. Disseminated intravascular coagulation or acute coagulopathy of trauma shock early after trauma? An observational study. Crit Care. 2011;15(6): R272.
6. World Health Organization. Injuries and violence. 19 March 2021. Available at: https://www.who.int/news-room/fact-sheets/detail/injuries-and-violence. Last accessed January 2023.
7. Pusateri AE, Moore EE, Moore HB, et al. Association of Prehospital Plasma Transfusion With Survival in Trauma Patients With Hemorrhagic Shock When Transport Times Are Longer Than 20 Minutes: A Post Hoc Analysis of the PAMPer and COMBAT Clinical Trials. JAMA Surg. 2020;155(2): e195085.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230202005552/en/
Contact information
Octapharma AG
Ivana Spotakova, Communications Manager
ivana.spotakova@octapharma.com, Tel.: +41793474607
Website: www.octapharma.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Spring 2023 Maxon One Release Adds Extraordinary Value29.3.2023 19:00:00 EEST | Press release
Maxon, developers of professional software solutions for editors, filmmakers, motion designers, visual effects artists and creators of all types, announced today a comprehensive update to Maxon One. Maxon’s Spring 2023 release offers exciting new features and workflow enhancements across the entire product line that will empower designers and artists to turn their creative ideas into reality with stunning results. Cinema 4D 2023.2 offers an improved Commander, enhancements to its Nodes system, simulation improvements and a new Thicken generator for modeling. Updates to the Red Giant toolset feature new tools and augmentations; most notably the introduction of Symbol Mapper for Universe 2023.1, anamorphic lens support for Real Lens Flares for VFX 2023.3, and Trapcode 2023.3 includes performance optimizations for Particular and a new collection of Atomic Age sprites. Redshift 3.5.14 brings a fantastic new Sky and Sun Model, a new Flakes Shader and new Camera Backplates. The latest releas
Nasdaq Congratulates Signifier Medical Technologies for Treating 10,000 Patients With eXciteOSA, a Daytime Therapy for Sleep Apnea29.3.2023 18:24:00 EEST | Press release
Signifier Medical Technologies LLC (“Signifier” or the “Company”), a Boston-based medical technology company, announces that eXciteOSA, the only FDA-authorized daytime therapy for sleep-disordered breathing, has treated over 10,000 patients since the commercial launch in 2021. Nasdaq recognized this milestone by congratulating Signifier Medical on the Nasdaq Tower in the heart of Times Square, New York. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230329005432/en/ (Photo: Business Wire) Akhil Tripathi, Signifier’s co-founder and CEO said, “This is a proud moment knowing that our therapy has made a positive impact on the lives of so many patients. It’s been a great team effort among our employees, clinicians, distributors, and most of all, our patients.” Signifier Medical is simplifying the complex standard of care for obstructive sleep apnea with eXciteOSA by tackling a root cause -- empowering patients to restore their ni
Flare gas reduction: Graforce a winner at Petronas Race2Decarbonise for groundbreaking solution29.3.2023 18:00:00 EEST | Press release
Out of more than 500 global solutions, Graforce was recognized at the Petronas Race2Decarbonise with its methane electrolysis technology (plasmalysis) in the category “Gas Flaring Reduction or Elimination.” The competition is aimed at accelerating the development of low-carbon solutions and reducing greenhouse gas emissions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230329005084/en/ Gas flaring causes more than 400 million tons of CO2 emissions every year. Graforce’s methane electrolysis technology is a groundbreaking solution that converts flare gas and other hydrocarbons into clean hydrogen and solid carbon. (Photo: Business Wire) Gas flaring results in more than 400 million tons of CO2 emissions every year. Thousands of gas flares at production sites around the globe burn approximately 150 billion cubic meters of natural gas each year, thus wasting a valuable resource. Plasmalysis, on the other hand, converts methane
SRMG launches new venture capital arm, SRMG Ventures, with first investments in regional content studio and immersive platform companies29.3.2023 17:36:00 EEST | Press release
SRMG, a global integrated media group, yesterday announced the launch of its corporate venture capital arm, SRMG Ventures. In line with SRMG’s transformative growth strategy, SRMG Ventures will invest in early-stage companies and technologies within the core target areas: media creators, digital media, media enablers and tools, including generative AI, as well as immersive and interactive entertainment. SRMG Ventures will initially target investments from the seed to Series B stage. SRMG Ventures will enable SRMG to back and empower regional talent and entrepreneurs, acting as a catalyst for further growth of the rapidly evolving media industry in the region. SRMG Ventures will provide SRMG with direct access to innovative technologies, as well as new media talent and content creators, that will continue to enhance SRMG’s own media portfolio and drive forward the future of media. The new corporate venture capital arm will additionally help SRMG penetrate new markets and further diversi
LambdaTest Upgrades its Playwright Automation Testing Experience With the Addition of its AI-Powered Integrated Test Intelligence29.3.2023 17:30:00 EEST | Press release
LambdaTest, an intelligent omnichannel digital experience testing cloud platform, has announced the addition of advanced AI-powered test intelligence features to its Playwright testing cloud offering. With this latest development, LambdaTest will now enable enterprises with deeper insights into their test execution process and help them better streamline their quality assurance process. LambdaTest has been constantly working on enhancing its Playwright automation testing cloud and the test intelligence feature is the latest addition to the list. Over the last quarter, LambdaTest has added features like support for browser extension testing, IP-based Geolocation testing, and Playwright component testing. Customers can soon test on Android real devices using Playwright as well. “Test intelligence is at the core of digital transformation in enterprises. Given Playwright’s increasing usage across the business world, we are excited to provide our customers with a deeper and more intuitive v
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom