{"id":27098,"date":"2026-06-26T18:23:00","date_gmt":"2026-06-26T16:23:00","guid":{"rendered":"http:\/\/stocks-future.com\/?guid=30c24dc5c204ca138496eb1e90cc39a4"},"modified":"2026-06-26T18:23:00","modified_gmt":"2026-06-26T16:23:00","slug":"pharmaessentia-announces-fda-approval-and-u-s-launch-of-besremi-pen-ropeginterferon-alfa-2b-njft-for-polycythemia-vera","status":"publish","type":"post","link":"https:\/\/stocks-future.com\/?p=27098","title":{"rendered":"PharmaEssentia Announces FDA Approval and U.S. Launch of BESREMi Pen\u2122 (ropeginterferon alfa-2b-njft) for Polycythemia Vera"},"content":{"rendered":"

\nNew pre-filled pen device enhances patient experience by simplifying self-administration<\/i><\/p>

BURLINGTON, Mass.--(BUSINESS WIRE)--PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation<\/a> (TWSE: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, today announced the U.S. Food and Drug Administration (FDA) approval and launch of the BESREMi Pen\u2122 (ropeginterferon alfa-2b-njft) device for adult patients with polycythemia vera (PV). The device offers a more convenient self-administration option than the currently available pre-filled syringe. The BESREMi Pen\u2122 is expected to become commercially available in the U.S. in the coming weeks.<\/p><\/a><\/a>

\n\u201cThe U.S. approval of the BESREMi Pen\u2122 is a significant milestone both for our company, as well as the patients we serve,\u201d said Samuel Lin, Head of Global Operations, PharmaEssentia. \u201cWith this new device, we\u2019re empowering more people living with PV to manage their condition with greater ease and confidence. It reflects our continued commitment to delivering not only innovative therapeutics, but also smarter, more intuitive ways to support long-term care.\u201d<\/p>

\n\u201cI\u2019m very excited to see the FDA approval of the BESREMi Pen\u2122 as a new option for patients,\u201d said Dr. John Mascarenhas, Director of the Center of Excellence for Blood Cancers and Myeloid Disorders at Mount Sinai in New York City. \u201cTreatment consistency is critical for managing PV, and this device has the potential to make a meaningful positive impact on patients\u2019 lives by simplifying self-administration and supporting better adherence.\u201d<\/p>

\nAbout PharmaEssentia\n<\/b>PharmaEssentia USA Corporation, located in Burlington, Massachusetts, is a subsidiary of PharmaEssentia Corporation (TWSE: 6446). PharmaEssentia Corporation, headquartered in Taipei, Taiwan, is a global and rapidly growing biopharmaceutical innovator. Leveraging deep expertise and proven scientific principles, PharmaEssentia aims to deliver effective new biologics for challenging diseases in the areas of hematology, oncology, and immunology with one approved product and a diversifying pipeline. Founded in 2003 by a team of Taiwanese-American executives and renowned scientists from U.S. biotechnology and pharmaceutical companies, today PharmaEssentia is expanding its global presence with operations in the U.S., Japan, China, and Korea, along with a world-class biologics production facility in Taichung, Taiwan.<\/p>

\nFor more information about PharmaEssentia USA, visit the website<\/a>, LinkedIn<\/a> or X (formerly Twitter)<\/a>.<\/p>

\nAbout Polycythemia Vera (PV)<\/b><\/p>

\nPolycythemia vera (PV) is a cancer originating from a disease-initiating stem cell in the bone marrow resulting in a chronic increase of red blood cells, white blood cells and platelets. PV may result in cardiovascular complications such as thrombosis and embolism, and often transforms to secondary myelofibrosis or leukemia. While the molecular mechanism underlying PV is still subject of intense research, current results point to a set of acquired mutations, the most important being a mutant form of JAK2.<\/p>

\nAbout BESREMi\u00ae (ropeginterferon alfa-2b-njft)\n<\/b>Ropeginterferon alfa-2b-njft is currently FDA-approved and marketed as BESREMi\u00ae for the treatment of adults with polycythemia vera (PV). The Company plans to seek a ropeginterferon alfa-2b-njft label expansion to include ET and has submitted a sBLA with the U.S. FDA.\nBESREMi\u00ae holds orphan drug designation in the United States for the treatment of polycythemia vera (PV) in adults. It has received regulatory approval in over 40 countries, including from the European Medicines Agency (2019), the U.S. Food and Drug Administration (2021), and the Pharmaceuticals and Medical Devices Agency in Japan (2023). The product was developed by PharmaEssentia. PharmaEssentia retains full global intellectual property rights across all indications.<\/p>

\nINDICATION\nBESREMi\u00ae is indicated for the treatment of adults with polycythemia vera.<\/p>

\nIMPORTANT SAFETY INFORMATION\nWARNING: RISK OF SERIOUS DISORDERS\nInterferon alfa products may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions. In many, but not all cases, these disorders resolve after stopping therapy.<\/p>

\nCONTRAINDICATIONS\nExistence of or history of severe depression, suicidal ideation, or suicide attempt\nHypersensitivity to interferons or any inactive ingredients\nModerate or severe hepatic impairment\nHistory or presence of active serious or untreated autoimmune disease\nHistory of transplantation and receiving immunosuppressant agents<\/p>

\nWARNINGS AND PRECAUTIONS\nPatients exhibiting the following events should be closely monitored and may require dose reduction or discontinuation of therapy:<\/p>