Pint Pharma Received ANVISA Approval for BESREMi® to Treat Polycythemia Vera
Friday, March 21, 2025
Pint Pharma and PharmaEssentia have received approval from ANVISA (Brazilian National Health Surveillance Agency) for BESREMi® (ropeginterferon alfa-2b) to treat adult patients with Polycythemia Vera (PV).
Polycythemia Vera is a rare, long-term blood disorder caused by abnormal stem cells in the bone marrow. This results in an excessive production of red blood cells, white blood cells, and platelets, increasing the risk of cardiovascular complications such as thrombosis and embolism. In some cases, the condition progresses to secondary myelofibrosis or leukemia.
The global incidence of PV is estimated at 2.8 cases per 100,000 people annually. In Brazil, DataSUS recorded 1,843 cases between 2016 and 2020, with an incidence rate of 0.16 per 100,000 inhabitants. The rarity of the disease, along with possible underdiagnosis and underreporting, presents challenges in identifying affected individuals.
The approval of BESREMi® in Brazil is considered a significant development for patients. As a long-acting, mono-pegylated interferon, the treatment has demonstrated effectiveness in maintaining hematological and clinical responses. The approval was based on findings from the PEGINVERA clinical trial, which showed better and more sustained outcomes compared to standard therapies.
Pint Pharma has exclusive rights to register, market, and distribute BESREMi® in Brazil. The treatment has already been approved in over 40 countries, including by the European Medicines Agency (EMA) in 2019, the US Food and Drug Administration (FDA) in 2021, and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) in 2023. Using advanced pegylation technology, BESREMi® provides prolonged activity in the body. It is administered every two weeks, with the option of every four weeks for patients who have maintained hematological stability for at least 1.5 years, allowing a more flexible treatment approach.
Source: businesswire.com
