We shouldn’t be against the hijab, Ms. Mohammadi remarked when asked about her opinions on the present discussion in India. On the contrary, we support giving women the freedom to decide whether or not to get married.
The LOW-PV trial, an independent investigator-initiated trial supported by AOP Health (Reference Barbui et al. ASH 2022), and the CONTINUATION-PV study, an AOP Health study on Ropeginterferon alfa-2b in patients with Polycythaemia Vera (PV), were presented at the ASH 2022 Annual Meeting in New Orleans, USA. I wear the hijab.
Including the investigations PEGINVERA, PROUD-PV, PEN-PV, CONTINUATION-PV, and (post-approval) PASS-PV, AOP Health has been running a critical clinical development program in Europe since 2010. With the help of this development effort, AOP Health was able to secure the European Commission’s (2019) first-ever marketing authorization for BESREMi® for treating polycythemia vera, followed by approvals from Switzerland, Liechtenstein, and Israel. In addition, the clinical development program of AOP Health served as the foundation for recent marketing authorizations in the USA in November 2021, as well as Taiwan, Korea, and, most recently, Korea.
AOP Health’s comprehensive drug research and commercialization competence are demonstrated by the numerous BESREMi® worldwide marketing authorizations that have already been granted, all of which were based on the clinical development program that the company ran in Europe. Our expertise and success enable us to continue working toward providing patients worldwide with access to medications for rare and exceptional diseases. Dr. Rudolf Widman, founder and board member of the AOP Health Group, stated.
The benefits of treatment are confirmed.
Prof. Jean-Jacques Kiladjian (Paris) presented findings from CONTINUATION-PV, an open-label, multicenter, phase IIIb study comparing the long-term (up to 7,3 years) effectiveness and safety of Ropeginterferon alfa-2b versus hydroxyurea (HU) or best available treatment, at the ASH 2022 Annual Meeting (BAT).
This latest study concentrated on safety and efficacy in PV patients with either high-risk or low-risk conditions. Both groups confirmed the advantages of Ropeginterferon alfa-2b therapy over BAT. The findings also indicated that low-risk patients might gain more, suggesting early therapy initiation. (Use Kiladjian et al., ASH 2022 as a source.)
The latter was a key finding of the Low-PV trial’s final results, which were given by Prof. Tiziano Barbui (Bergamo): Ropeginterferon alfa-2b treatment outperformed phlebotomy-only care in maintaining hematocrit objectives in a population of early, low-risk PV patients. (See ASH 2022; Barbui et al.)
Ropeginterferon alfa-2b has become the chosen first-line therapy for many PV patients since it was first approved in Europe in 2019, according to Prof. Barbui, and it has already caused a change in the way that patients with P. vera are treated, as shown by the amended ELN treatment guidelines. (Inspired by Marchetti et al., 2022.)
About BESREMi®
The treatment of people with polycythemia vera, a myeloproliferative neoplasm (MPN), without symptomatic enlargement of the spleen is indicated in the European Union using BESREMi®, the first and only interferon currently approved for the condition. Several clinical trials have proven its general efficacy and safety.
Mono-pegylated proline interferon BESREMi® (ropeginterferon alfa-2b) is a long-acting interferon (ATC L03AB15). Once the blood values have stabilized, it is delivered once every two weeks at first and then up to four weeks later. BESREMi® is made to be applied subcutaneously by the user using a pre-filled pen.
Please visit BESREMi® to get the EMA Summary of Product Characteristics.
About AOP Health
The AOP Health Group, which has its headquarters in Vienna, Austria (“AOP Health”), consists of several businesses, including AOP Orphan Pharmaceuticals GmbH. The AOP Health Group is a leader in European integrated medicines for critical care and uncommon diseases. The Group has established itself as a leading provider of comprehensive therapeutic solutions over the past 25 years, working from its Vienna-based headquarters, its subsidiaries, and representative offices across Europe and the Middle East, as well as through partners globally.
A consistently high level of investment in research and development, on the one hand, and a highly consistent and practical orientation towards the needs of all its stakeholders, particularly the patients and their families as well as the healthcare professionals treating them, on the other, have made this development possible.