BURLINGTON, Mass. — The U.S. Food and Drug Administration has accepted PharmaEssentia USA Corporation’s supplemental Biologics License Application for ropeginterferon alfa-2b-njft for the treatment of adult patients with essential thrombocythemia, setting a PDUFA goal date of August 30, 2026.
PharmaEssentia said the FDA classified the submission under a standard review and completed its filing review without identifying any issues, allowing the application to move forward for substantive evaluation. If approved, the sBLA would expand the product label for BESREMi (ropeginterferon alfa-2b-njft) to include adult patients with essential thrombocythemia, a rare blood cancer characterized by excessive platelet production.
“ET is a rare blood cancer driven by excessive platelet production that can result in severe complications like organ damage and stroke. Despite these serious risks, no new therapies have been approved by the FDA for over two decades,” said Ko-Chung Lin, Ph.D., Founder and CEO of PharmaEssentia. “We look forward to collaborating with the FDA as they review our application, with the goal of bringing ropeginterferon alfa-2b-njft, an investigational therapy, to the ET community as quickly as possible.”
The application is supported by data from the global Phase 3 SURPASS-ET clinical trial as well as confirmatory evidence from the North American Phase 2b EXCEED-ET study. PharmaEssentia said the trials demonstrated statistically significant and clinically meaningful outcomes in patients with essential thrombocythemia. Any final approved indication and updates to prescribing information will be determined during the FDA review process.
“Living with ET can be exhausting—physically and emotionally—for patients who must navigate a chronic cancer with limited treatment choices,” said Ruben Mesa, M.D., principal investigator of the SURPASS-ET trial and President of Advocate Health’s Cancer National Service Line. “If approved, ropeginterferon alfa-2b-njft could offer clinicians a meaningful new treatment option for their patients with ET.”
PharmaEssentia USA is a subsidiary of PharmaEssentia Corporation, a Taiwan-based biopharmaceutical company focused on developing biologic therapies in hematology and oncology.
