Shots:
- The US FDA has accepted sBLA of ropeginterferon alfa-2b-njft for the treatment of adults with essential thrombocythemia, with a PDUFA target action date of Aug 30, 2026
- sBLA is supported by the statistically significant and clinically meaningful data from the P-III (SURPASS-ET) trial as well as North American P-IIb (EXCEED-ET) trial
- Ropeginterferon alfa-2b-njft received FDA approval in Dec 2021 & marketed as BESREMi for the treatment of adults with polycythemia vera
Ref: Businesswire | Image: PharmaEssentia | Press Release
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