Shots:
- The US FDA has approved Yartemlea for the treatment of HSCT-Associated Thrombotic Microangiopathy, with US launch planned for Jan 2026. MAA is under the EMA’s review, with a decision expected in mid-2026
- Approval was based on the TA-TMA Study (n=28) plus EAP (N=221 adults & pediatric pts), where 19 pts (13 adult & 6 pediatric) in the EAP had evaluable patient-level response data
- Trials showed Yartemlea improved TMA complete response, with CR in 17/28 TA-TMA Study pts & 13/19 EAP pts, plus showed 73% & 74% 100-day survival, respectively. In the peer-reviewed publications, Yartemlea was associated with 3-4x lowered mortality & higher 1yr. survival even in refractory high-risk pts
Ref: Business Wire | Image: Omeros | Press Release
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