AOP Health presents latest updates on BESREMi® (Ropeginterferon alfa-2b) in Polycythaemia Vera at the American Society of Hematology (ASH) 2022 Annual Meeting
AOP Health announced its latest updates on Ropeginterferon alfa-2b in patients with Polycythaemia Vera (PV) from AOP Health´s CONTINUATION-PV study (Reference Kiladjian et al. ASH 2022) and the LOW-PV trial, which is an independent investigator-initiated trial supported by AOP Health (Reference Barbui et al. ASH 2022) presented at ASH 2022 Annual Meeting, New Orleans, USA.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20221213005003/en/
Prof. Tiziano Barbui Photocredit: AOP Health/Filippo Capaccioli (Photo: Business Wire)
AOP Health has been conducting a pivotal clinical development program in Europe since 2010, including the studies PEGINVERA, PROUD-PV, PEN-PV, CONTINUATION-PV and (post-approval) PASS-PV. With this development program AOP Health obtained the first marketing authorization ever of BESREMi® for the treatment of Polycythaemia Vera by the European Commission (2019), followed by Switzerland, Liechtenstein and Israel. AOP Health's clinical development program was also the basis for marketing authorization in Taiwan, Korea and most recently in the USA in November 2021.
“The by now 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 at AOP Health. Our success and know-how allow us to further pursue our goal of making drugs for rare and special diseases available to patients worldwide.” commented Dr. Rudolf Widman, Founder and Member of the Board of the AOP Health Group.
Benefits of treatment confirmed
During the ASH 2022 Annual Meeting Prof. Jean-Jacques Kiladjian (Paris) presented results on final data of AOP Health´s CONTINUATION-PV, an open-label, multicenter, phase IIIb study assessing the long-term (up-to 7,3 years) efficacy and safety of Ropeginterferon alfa-2b versus hydroxyurea (HU) or best available treatment (BAT). This new analysis focused on efficacy and safety on either high-risk or low-risk PV patients. The benefits of treatment with Ropeginterferon alfa-2b over BAT, were confirmed in both groups. The results further suggested that low-risk patients may benefit more, thus supporting early treatment start. (Reference Kiladjian et al. ASH 2022)
The latter was also a main conclusion from the final results of the Low-PV trial, presented by Prof. Tiziano Barbui (Bergamo): In an early, low-risk PV patient population treatment with Ropeginterferon alfa-2b proved superior in maintaining haematocrit targets, as compared to management by phlebotomy only. (Reference Barbui et al. ASH 2022)
Prof. Barbui said, “Since its first approval in Europe in 2019, Ropeginterferon alfa-2b has become the first line therapy of choice for many PV patients and has already led to a change of treatment paradigm for patients with P. vera as reflected by the updated ELN treatment guidelines.” (Reference to Marchetti et al. 2022)”
About BESREMi®
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 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®
Link BESREMi ® Summary of Product Characteristics: https://www.ema.europa.eu/en/documents/product-information/besremi-epar-product-information_en.pdf
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. This development has been made possible by a continually high level of investment in research and development on the one hand and a highly consistent and pragmatic orientation towards the needs of all its stakeholders on the other – especially the patients and their families as well as also 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20221213005003/en/
Contact information
Mag. Nina Roth
Nina.Roth@aop-health.com
+43-676-3131509
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
RTL Luxembourg Expands Deployment of Verimatrix Technologies to Protect Premier Auto Racing Against Piracy11.9.2025 18:45:00 EEST | Press release
Regulatory News: Verimatrix, (Euronext Paris: VMX), a leading provider of security solutions for a safer connected world, today announced that RTL Luxembourg, the country’s leading media company, has further expanded its use of Verimatrix anti-piracy tools to now include the full Streamkeeper suite of solutions. Initially deploying Streamkeeper Multi-DRM, RTL Luxembourg also recently implemented Counterspy, Deepscan and Watermarking solutions – the industry’s latest set of powerful tools that help further bolster proactive protections for RTL’s motorsport content revenue. It was announced in April 2024 that RTL Luxembourg selected Verimatrix Streamkeeper Multi-DRM to ensure that RTL Luxembourg remained in full control of its valuable digital assets while also consistently keeping costs low and preventing unneeded technical complexities. With the addition of Verimatrix’s Counterspy, RTL Luxembourg further expands its ability to detect unauthorized content distribution in real-time, depl
Xylem and Amazon Partner on Smart Water Upgrades to Save More Than 1.3 Billion Liters Annually in Mexico11.9.2025 17:00:00 EEST | Press release
Residents in Mexico City and Monterrey will soon enjoy more reliable water supply as the two cities launch groundbreaking infrastructure upgrades to save over 1.3 billion liters of water a year – easing pressure from the rapid urbanization and persistent drought conditions that have strained local water systems. The two cities are working in partnership with global water technology company Xylem (NYSE: XYL) and Amazon (NASDAQ: AMZN) to deploy Xylem Vue, an advanced software platform that applies data and analytics to detect leaks, cut water losses and improve residents’ water supply. The projects are estimated to save upwards of 800 million liters of water a year in Mexico City and 560 million liters a year in Monterrey. “In a water-stressed region, where every liter counts, recovering more than a billion liters of water each year is a game-changer,” said Jaime Barba, General Manager, Xylem Vue. “Working with Amazon and the local water utilities, we are using data to give these cities
HTEC Partners with World Economic Forum11.9.2025 16:56:00 EEST | Press release
HTEC, a global digital engineering and product development company, has today announced that it has joined the World Economic Forum’s (WEF) Centre for AI Excellence. HTEC will contribute to the community through its expertise and thought leadership to help advance AI adoption and AI innovation across its core industries. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250911910448/en/ HTEC Partners with World Economic Forum to bring AI expertise to help with industry transformation and real-world outcomes WEF’s Centre for AI Excellence is bringing together leading industry organisations and experts to work together to advance the pace and positive impact AI can have in economies and societies. Its goal is to unlock transformative potential in an equitable and human-centered way, which is well aligned with HTEC’s principles and values. As an AI-first organization, HTEC blends deep engineering expertise with strategic insight.
Alipay Tap! Users Reach 200 Million, Expands to Over 1,000 Scenarios Beyond Payments11.9.2025 16:31:00 EEST | Press release
Alipay announced today at the 2025 INCLUSION · Conference on the Bund in Shanghai that its QR code-based contactless payment and engagement solution, Alipay Tap!, has rapidly grown its user base to 200 million since its launch in China in June 2024. The milestone comes just months after surpassing 100 million users in April 2025. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250911881010/en/ With Alipay Tap!, users can open a vending machine with a simple tap Designed to be simpler than QR code scanning, Alipay Tap! lets users complete a transaction or access a service by simply tapping their unlocked phone on a merchant’s terminal or Alipay Tap! Tag, eliminating the need to open an app, scan a code, or navigate multiple screens. As Alipay evolves from a digital wallet into a comprehensive platform connecting 1 billion consumers with 80 million merchants nationwide, Alipay Tap! has become a hassle-free gateway to its ecosys
Vertex Scientists Awarded the 2025 Lasker~DeBakey Clinical Medical Research Award for Pioneering Discoveries in Cystic Fibrosis11.9.2025 16:05:00 EEST | Press release
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Senior Vice President Paul Negulescu has been named as one of the winners of this year’s Lasker~DeBakey Clinical Medical Research Award for his role “in the development of a novel, life-saving treatment for cystic fibrosis (CF) — namely, a triple-drug combination therapy, TRIKAFTA®, that has helped countless people with this genetic disease.” Dr. Negulescu is one of three awardees, alongside Jesús (Tito) González, a former Vertex scientist, and Michael Welsh, Professor of Internal Medicine-Pulmonary, Critical Care and Occupational Medicine, University of Iowa. The prize honors the groundbreaking work of Dr. Negulescu, Dr. González and the entire Vertex team who discovered and developed the first and only approved medicines that address the underlying cause of CF. To date, Vertex has brought five transformational medicines to patients with CF which have fundamentally changed the way this disease is treated. “I’m hon
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