FDA Approves BESREMi Pen, Expanding Self-Administration Options for Patients With Polycythemia Vera
Clinical Summary:
- The FDA has approved the BESREMi Pen, a prefilled pen delivery device for ropeginterferon alfa-2b-njft, for adults with polycythemia vera receiving chronic interferon therapy.
- The pen-based device is designed to simplify self-administration compared with the previously available prefilled syringe, providing a more convenient at-home administration option that may support treatment adherence and long-term disease management.
- The approval introduces a new delivery option for BESREMi that may reduce barriers to chronic therapy, particularly for patients initiating treatment or transitioning from other therapies.
On June 29, 2026, the US Food and Drug Administration (FDA) approved the BESREMi Pen, a prefilled pen delivery device for ropeginterferon alfa-2b-njft, for adult patients with polycythemia vera.
BESREMi is a long-acting interferon therapy indicated for the treatment of adults with polycythemia vera, a rare, chronic myeloproliferative neoplasm characterized by increased production of red blood cells and an elevated risk of thrombotic events. Most patients with polycythemia vera harbor mutations in the JAK2 gene, and without appropriate management, the disease may progress to myelofibrosis or acute leukemia.
The newly approved prefilled pen is designed to simplify self-administration by providing an alternative to the previously available prefilled syringe. The device is designed for at-home use and may offer a more convenient administration experience for patients receiving long-term interferon therapy.
According to PharmaEssentia, BESREMi has received orphan drug designation in the United States and is approved in more than 40 countries, including those in the European Union and Japan.
For oncology nurses, the availability of the BESREMi Pen may support more intuitive patient education and chronic care management. The pen-based delivery system is intended to help patients administer treatment at home with greater convenience and may reduce barriers to consistent treatment use, particularly among patients newly diagnosed with polycythemia vera or those transitioning from other therapies.
“This device has the potential to make a meaningful positive impact on patients’ lives by simplifying self-administration and supporting better adherence,” stated John Mascarenhas, MD, Ichan School of Medicine at Mount Sinai, New York, New York.
Source:
PharmaEssentia USA. FDA Approves BESREMi Pen for Polycythemia Vera Self-Administration. Chemdiv.com. Published 2026. Accessed July 1, 2026. https://www.chemdiv.com/company/media/pharma-news/2026/fda-approves-besremi-pen-for-polycythemia-vera-self-administration/
