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.
