AOP Health: Completed Study Strengthens Clinical Development Program for ropeginterferon alpha 2b (Besremi®) in polycythaemia vera
With the publication of the final results from the LOW-PV study in the New England Journal of Medicine Evidence conducted by Fondazione per la Ricerca dell'Ospedale di Bergamo (FROM) under the leadership of Professor Tiziano Barbui, AOP Health announces an important advancement reinforcing its clinical development program for ropeginterferon alpha-2b (BESREMi®) in polycythaemia vera (PV), a rare blood cancer. The academic LOW-PV study supported and funded by AOP Health and public organizations in Italy complements a series of trials performed by AOP Health over more than 10 years to achieve marketing authorization in Europe and the Middle East. With these clinical studies, including PEGINVERA,PROUD-PV, and CONTINUATION-PV, AOP Health opened a new area of treatment options for patients suffering from PV. A further study (PEN-PV) was performed to develop a pen for self-injection allowing ease of self-administration, exact dosing and minimal waste of the medical product. AOP Health’s comprehensive development program in PV is considered by many key opinion leaders as the most significant development in the field of PV treatment in the past 30 years.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230601005759/en/
Dr. Rudolf Widmann, Founder and Board Member of the AOP Health Group/ Copyright: Studio Koekart: Natasche Unkart & Isabella Köhler (Photo: Business Wire)
This series of studies has enabled marketing authorizations to be obtained in numerous countries in addition to the AOP Health territories EU, Switzerland, Liechtenstein and Israel and allows patients to have access to BESREMi® in countries including Taiwan, Korea, the US, and Japan. Further studies are ongoing to substantiate the long-term safety and efficacy of BESREMi®. A post-approval safety study (BESREMI-PASS) with a recruitment period of about three years has just completed patient recruitment.
“The global marketing authorizations of BESREMi®, all based on AOP Health´s clinical development program conducted in Europe, are proof of the integrated drug development and commercialization expertise of AOP Health. Our success and know-how allow us to further pursue our goal of making treatment options for rare diseases available to patients worldwide” says Dr. Rudolf Widman, Founder and Board Member of the AOP Health Group.
BESREMi® is the first and currently only interferon approved for polycythaemia vera, a myeloproliferative neoplasm (MPN), indicated in the European Union as monotherapy in adults for treatment of polycythaemia vera without symptomatic enlarged spleen. Its overall safety and efficacy were demonstrated in multiple clinical studies.
BESREMi® (ropeginterferon alfa-2b) is a long-acting, mono-pegylated proline interferon (ATC L03AB15). It is administered with a pen (250 and 500 ug) for self-injection once every 2 weeks initially, or up to every 4 weeks after stabilization of blood values. BESREMi® is designed to be self-administered subcutaneously with a pre-filled pen.
For the EMA Summary of Product Characteristics please visit: BESREMi®
The drug substance Ropeginterferon alfa-2b was discovered by PharmaEssentia, a long-term partner of AOP Health. In 2009, AOP Health in-licensed the exclusive rights for clinical development and commercialization of ropeginterferon alfa-2b in polycythaemia vera and other MPNs such as chronic myelogenous leukemia (CML) for European, Commonwealth of Independent States (CIS), and Middle Eastern markets.
About AOP Health
The AOP Health Group incorporates several companies including AOP Orphan Pharmaceuticals GmbH with its seat in Vienna, Austria (“AOP Health”). The AOP Health Group is the European pioneer for integrated therapies for rare diseases and in critical care. Over the past 25 years, the Group has become an established provider of integrated therapy solutions operating from its headquarters in Vienna, its subsidiaries and representative offices throughout Europe and the Middle East, as well as through partners worldwide. The claim “Needs. Science. Trust.” sums up the foundation of the Group’s success: establishing trust through a continually high level of investment in research and development and a highly consistent and pragmatic orientation towards the needs of all stakeholders – especially the patients and their families as well as the healthcare professionals treating them.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
DI Isolde Fally
From the US: 011-43-676-500 4048
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
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
SLB Launches First-of-Its-Kind, Easy-to-Install Methane Measurement Instrument4.10.2023 04:00:00 CEST | Press release
SLB’s End-to-end Emissions Solutions (SEES) business today introduced its next generation methane point instrument, a self-installed continuous methane monitoring system that uses IoT-enabled sensors to quickly and cost effectively detect, locate and quantify emissions across oil and gas operations. Effective monitoring is essential to reduce emissions of methane, a greenhouse gas (GHG) which has a climate change impact up to 84 times greater than carbon dioxide over a 20-year timescale and represents about half of the oil and gas sector’s operational emissions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20231003896530/en/ The compact, self-install device for continuous methane monitoring enables fast, affordable deployment at any scale. (Photo: Business Wire) The methane point instrument represents a step change in methane measurement technology, providing operators with industry-leading leak detection sensitivity in a sm
"HD-PLC Alliance" is renamed "Nessum Alliance" as it enters a New Era of Wired and Wireless (Any Media) IoT Communication Applications!4.10.2023 03:00:00 CEST | Press release
HD-PLC*1 Alliance announced that it has changed its name from "HD-PLC Alliance" to "Nessum*2 Alliance" (hereinafter referred to as "Alliance") to promote the next generations of IEEE 1901*3 standards for wired and wireless (Any Media) communication for the Industrial IoT market. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20231003535815/en/ Society and Lifestyles with Nessum (Graphic: Business Wire) As a background to this change of name to "Nessum Alliance", after Panasonic's communication technology based on the Wavelet OFDM PHY/MAC technology*4 was approved as Draft 1.0 in the working group in August for the next-generation communication standard IEEE P1901c*5 of the IEEE Standards Association which the Alliance and its members participate in, Panasonic changed the brand name of the communication technology "HD-PLC" to "Nessum" last month*6. In response to this, the Alliance has changed its organization name in order to
Takeda’s Dengue Vaccine Recommended by World Health Organization Advisory Group for Introduction in High Dengue Burden and Transmission Areas in Children Ages Six to 16 Years3.10.2023 22:50:00 CEST | Press release
Takeda (TSE:4502/NYSE:TAK)today announced that the World Health Organization’s (WHO) Strategic Advisory Group of Experts (SAGE) on Immunization shared recommendations for use of QDENGA®▼ (Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003). In the coming months, the WHO will consider the SAGE recommendation and update its position paper on dengue vaccines to include final guidance on the use of QDENGA in public vaccination programs. SAGE made the following recommendations: The vaccine to be considered for introduction in settings with high dengue disease burden and high transmission intensity to maximize the public health impact and minimize any potential risk in seronegative persons. The vaccine to be introduced to children aged 6 to 16 years of age. Within this age range, the vaccine should be introduced about 1-2 years prior to the age-specific peak incidence of dengue-related hospitalizations. The vaccine should be administered in a 2-dose schedule with a 3-month interval betw
Verimatrix To Showcase Cybersecurity Solutions at GovWare 20233.10.2023 17:45:00 CEST | Press release
Regulatory News: Verimatrix, (Euronext Paris: VMX), the leader in powering the modern connected world with people-centered security, today announced it will highlight its Extended Threat Defense (XTD) technologies at GovWare 2023 taking place October 17-19 at Singapore’s Sands Expo and Convention Centre. Located in GovWare booth C19, Verimatrix will offer hands-on demonstrations as well as customer success stories for its portfolio of award-winning XTD cybersecurity solutions that enable mobile app developers to harness the latest protections against hackers seeking to use mobile apps and websites as tools to attack enterprises. GovWare 2023 promises yet another invigorating event where knowledge, ideas, insights and technologies will be shared among cybersecurity leaders and innovators. Under the theme “Fostering Trust Through Collaboration in the New Digital Reality,” GovWare 2023, a part of the renowned Singapore International Cyber Week (SICW), is set to deliver transformative insi
Evolve Additive Solutions Announces Strategic Partnership with alphacam to Provide STEP Parts Production in Europe3.10.2023 16:00:00 CEST | Press release
Evolve Additive Solutions, provider of industrial 3D printing solutions and inventor of the transformative Selective Thermoplastic Electrophotographic Process (STEP), announces a strategic partnership with alphacam GmbH to offer STEP-manufactured parts as a service to customers throughout Europe. STEP is a groundbreaking additive manufacturing technology that addresses the manufacturing constraints in accuracy, scalability and engineering-grade materials by other technologies in market today. alphacam will combine its deep industry expertise, vast experience in printing plastic parts, and strong customer relationships with its adoption of Evolve’s Scaled Volume Production (SVP) platform to produce and deliver fully dense, high-fidelity thermoplastic parts with near injection molding surface finish and properties. This marks the 2nd partnership of this kind introduced by Evolve as part of its mission to establish STEP production centers of excellence around the world – ultimately to inc