Pint Pharma Secures ANVISA Approval for BESREMi® in PV Treatment
Pint Pharma and PharmaEssentia announced today that ANVISA (Brazilian Health Regulatory Agency) has approved BESREMi® (ropeginterferon alfa-2b) for the treatment of adult patients with Polycythemia Vera (PV). This milestone marks a significant advancement in the management of this rare and potentially fatal myeloproliferative neoplasm.
Polycythemia Vera (PV) is a chronic blood disorder originating from a disease-initiating stem cell in the bone marrow. It leads to an excessive production of red blood cells, white blood cells, and platelets, which increases blood viscosity and the risk of severe cardiovascular complications, such as thrombosis and embolism. PV can also progress to secondary myelofibrosis or leukemia in some patients. Due to its progressive nature, timely diagnosis and effective treatment are crucial for improving patient outcomes and quality of life.
The global incidence of PV is estimated at approximately 2.8 cases per 100,000 people per year. In Brazil, DataSUS recorded 1,843 cases of Polycythemia Vera between 2016 and 2020, corresponding to an incidence rate of 0.16 per 100,000 inhabitants. Despite being classified as a rare disease, these figures may not fully represent the actual prevalence due to potential underdiagnosis and underreporting. Raising awareness among healthcare professionals and improving diagnostic methods remain key challenges in addressing PV effectively.
ANVISA’s approval of BESREMi® offers a new therapeutic option for Brazilian patients suffering from PV. According to Fernanda Bertasi, General Manager of Pint Pharma in Brazil, “ANVISA’s approval of BESREMi® represents a transformative milestone for patients with Polycythemia Vera in Brazil. This new therapeutic option brings real hope, offering innovation and progress in disease treatment. This is an essential step in providing better health and well-being for these patients.”
BESREMi® is a next-generation, monopegylated interferon designed for long-acting therapeutic effects. Its extended activity is attributed to its unique pharmacokinetic properties, which enable sustained efficacy with fewer injections compared to conventional treatments. This innovation is expected to improve treatment adherence and overall patient experience. Valnei Canutti, Hematologist and Chief Scientific Officer at Pint Pharma, emphasized that “BESREMi® is an innovative, monopegylated interferon with extended action due to its unique pharmacokinetic properties. Its approval was based on robust evidence from the PEGINVERA clinical study, which demonstrated superior and more sustained hematologic and clinical responses compared to standard therapy.”
The PEGINVERA clinical trial played a crucial role in securing regulatory approval. The study demonstrated that BESREMi® effectively controls hematocrit levels, reduces the need for phlebotomy, and improves overall blood count stability in PV patients. The trial further showed that patients receiving BESREMi® experienced longer-lasting remissions and improved tolerability compared to conventional treatments. These findings reinforce its potential as a game-changer in PV management, offering an alternative to traditional cytoreductive therapies with a more favorable safety profile.
For David Ricardo Muñoz Guzmán, CEO of Pint Pharma, “This therapeutic advancement reaffirms Pint Pharma’s commitment to being a community-centered company. Our mission goes beyond innovation and high technology, focusing on solutions that truly impact patients’ lives by expanding access to treatments and improving healthcare quality.”
Ko-Chung Lin, Ph.D., Founder and CEO of PharmaEssentia, added, “The approval of BESREMi® by ANVISA is a testament to the power of strong cross-border partnerships in advancing healthcare and reinforces our mission to transform care for PV patients worldwide. We deeply appreciate the collaboration with the Pint Pharma team, whose expertise and dedication have been instrumental in bringing BESREMi® to patients in Brazil.”
The approval of BESREMi® in Brazil aligns with a growing global recognition of the need for improved PV treatments. The drug has already been approved in several other regions, including the United States and Europe, where it has been integrated into treatment guidelines for PV. As a long-acting interferon, BESREMi® provides an alternative treatment approach for patients who may not respond well to or tolerate conventional cytoreductive therapies such as hydroxyurea.
Beyond its role in PV management, BESREMi® represents a significant step forward in the evolution of interferon-based therapies. By leveraging advanced pegylation technology, PharmaEssentia has developed a product that maintains efficacy while minimizing side effects, addressing key limitations of traditional interferon therapies. This innovation opens the door for further research into potential applications of ropeginterferon alfa-2b in other hematological disorders.
Pint Pharma, as the exclusive partner responsible for the registration, marketing, and distribution of BESREMi® in Brazil, is committed to ensuring widespread patient access to this novel therapy. The company is working closely with healthcare providers, patient advocacy groups, and regulatory bodies to facilitate early adoption and integration into clinical practice. Efforts are also underway to secure reimbursement and inclusion in national treatment protocols to make BESREMi® accessible to a broader patient population.
With the approval of BESREMi®, Brazilian patients now have access to an innovative and effective treatment option for Polycythemia Vera. This milestone underscores the importance of continued investment in research, regulatory collaboration, and patient-centered healthcare solutions. As Pint Pharma and PharmaEssentia move forward, they remain committed to their shared vision of improving outcomes for patients with rare hematological diseases worldwide.
