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Shots:
- Omeros submitted an MAA to the EMA for narsoplimab to treat TA-TMA, with data demonstrating a 61% response rate and a 3x improvement in OS vs matched external controls; over 130 pts treated under expanded access data were also included
- EMA granted Narsoplimab ODD status, and CHMP review will start mid-July under centralized procedure, with a final decision expected by mid-2026
- Narsoplimab is also under the US FDA review with a PDUFA date of Sept 25, 2025; it also holds ODD and BTD for TA-TMA and ODD for the inhibition of complement-mediated thrombotic microangiopathies
Ref: Businesswire | Image: Omerus| Press Release
Related News:- Omeros Reports the US FDA’s Acceptance of Resubmitted BLA for Narsoplimab to Treat TA-TMA
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