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VIENNA — AOP Orphan Prescription drugs GmbH (AOP Well being) introduced the publication of ultimate outcomes on the lately developed interferon remedy, ropeginterferon alfa-2b, in sufferers with polycythemia vera (PV) within the prestigious journal Leukemia1. The total publication expands on outcomes offered on the Annual Assembly of the European Hematology Affiliation. Outcomes of long-term therapy within the CONTINUATION-PV research present additional proof of the illness modifying capability of ropeginterferon alfa-2b in PV.
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“AOP Well being has invested in a complete medical analysis program for ropeginterferon alfa-2b in PV, which has led to the approval by the well being authorities in a number of nations. We’re very proud that our scientific work has contributed to addressing the questions which might be necessary to sufferers”, says Dr. Rudolf Widman, Founder and Board Member of the AOP Well being Group.
Professor Heinz Gisslinger from the Medical College of Vienna, the primary writer of the paper, provides: “Ropeginterferon alfa-2b is already established as an efficient first-line therapy for sufferers with PV. These new outcomes counsel that its potential must be thought-about when evaluating therapy choices.”
Ropeginterferon alfa-2b is a long-acting, mono-pegylated proline interferon (ATC L03AB15). It’s administered as soon as each 2 weeks initially, or as much as month-to-month following stabilization of hematological parameters.
AOP Well being’s pivotal medical growth program for ropeginterferon alfa-2b contains the research PEGINVERA, PROUD-PV and CONTINUATION-PV. The latter is an open-label, multicenter, section IIIb research assessing the long-term efficacy and security of ropeginterferon alfa-2b versus hydroxyurea (HU) or greatest accessible therapy (BAT) in sufferers with high-risk or low-risk PV who beforehand participated within the randomized, managed PROUD-PV research.
Scientific analysis performed by AOP Well being in Europe since 2010 has led to advertising authorization of BESREMi® for the therapy of PV, first granted by the European Fee in 2019, and thereafter by Switzerland, Liechtenstein, Israel, Bahrain, Taiwan, South Korea, Japan and the USA.
1 Gisslinger, H., Klade, C., Georgiev, P. et al. Occasion-free survival in sufferers with polycythemia vera handled with ropeginterferon alfa-2b versus greatest accessible therapy. Leukemia (2023). https://doi.org/10.1038/s41375-023-02008-6
About Polycythemia Vera
Polycythemia Vera (PV) is a uncommon most cancers of the blood-building stem cells within the bone marrow leading to a continual enhance of pink blood cells, white blood cells and platelets. This situation will increase the chance for circulatory problems reminiscent of thrombosis and embolism, its signs result in a lowered high quality of life and on the long term could progress to myelofibrosis or rework to leukemia. Whereas the molecular mechanism underlying PV remains to be topic of intense analysis, present outcomes level to blood-building stem cells within the bone marrow with a set of acquired mutations, crucial being a mutant type of JAK2 that make up the malignant clone.
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Essential PV therapy objectives are to attain wholesome blood counts (hematocrit under 45%), enhance high quality of life and to gradual or delay the development of illness.
About AOP Well being
The AOP Well being Group incorporates a number of corporations together with AOP Orphan Prescription drugs GmbH with its seat in Vienna, Austria (“AOP Well being”). The AOP Well being Group is the European pioneer for built-in therapies for uncommon illnesses and in vital care. Over the previous 25 years, the Group has turn out to be a longtime supplier of built-in remedy options working from its headquarters in Vienna, its subsidiaries and consultant places of work all through Europe and the Center East, in addition to by way of companions worldwide. This growth has been made doable by a regularly excessive degree of funding in analysis and growth on the one hand and a extremely constant and pragmatic orientation in the direction of the wants of all its stakeholders on the opposite – particularly the sufferers and their households in addition to additionally the healthcare professionals treating them.
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Contacts
DI Isolde Fally
AOP Orphan Prescription drugs GmbH
Member of the AOP Well being Group
Isolde.Fally@aop-health.com
+43-676-500 4048
aop-health.com
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