Shots:
- The US FDA has accepted the Class 2 BLA resubmission of narsoplimab for the treatment of HSCT-associated thrombotic microangiopathy (TA-TMA), with PDUFA goal date assigned in late Sept 2025; EMA’s MAA filing expected by late Q2’25
- The BLA resubmission incl. primary set of survival analyses, showing improved OS in TA-TMA pts, along with survival data from Omeros’ expanded access program in which adult & pediatric TA-TMA pts were dosed with narsoplimab
- Narsoplimab (OMS721) is a fully human mAb that targets MASP-2, a pro-inflammatory enzyme in the lectin complement pathway while leaving the antibody-dependent classical complement pathway unaffected
Ref: Omeros | Image: Omeros
Related News:- Regeneron Reports US FDA’s Acceptance of Resubmitted BLA for Linvoseltamab to Treat R/R Multiple Myeloma (MM)
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