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# FDA Approves BESREMi Pen for Polycythemia Vera
- URL: https://www.fdaweb.com/fda-approves-besremi-pen-for-polycythemia-vera/
- Published: 2026-07-06T12:00:00.000Z
- Updated: 2026-09-14T13:42:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161394

FDA has approved PharmaEssentia’s BESREMi Pen (ropeginterferon alfa-2b-njft) for polycythemia vera (PV). A company [statement](https://us.pharmaessentia.com/pharmaessentia-announces-fda-approval-and-u-s-launch-of-besremi-pen-ropeginterferon-alfa-2b-njft-for-polycythemia-vera/?ref=fdaweb.com) says PharmaEssentia plans to submit a sBLA to FDA seeking a broader indication to include essential thrombocythemia. FDA previously granted an orphan drug designation for BESREMi to treat PV in adults.