Vienna, Austria:
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)”
