When will Omeros' Yartemlea be available?

Omeros expects Yartemlea to be available on the market by January 2026.

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FDA Approves First Drug for Transplant Complication

Q: What is the new FDA-approved drug Yartemlea for?

Yartemlea is approved for treating transplant-associated thrombotic microangiopathy (TA-TMA), a complication after stem cell transplants.

Q: What causes transplant-associated thrombotic microangiopathy (TA-TMA)?

TA-TMA is caused by an overactive immune system damaging blood vessels during or after a stem cell transplant, leading to blood clots.

24 Dec, 2025

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Summary

FDA approved Omeros' Yartemlea for transplant-associated thrombotic microangiopathy.
This marks the first-ever treatment authorized for the dangerous condition.
The drug is expected to be available on the market by January 2026.

FDA Approves First Drug for Transplant Complication

The U.S. Food and Drug Administration has granted approval for Yartemlea, a groundbreaking drug developed by Omeros. This marks a significant milestone as it is the first treatment to receive authorization for transplant-associated thrombotic microangiopathy (TA-TMA).

TA-TMA is a perilous complication that can arise following stem cell transplants, particularly those involving donor cells. It stems from an overactive immune system damaging blood vessels, leading to blood clots that can impair vital organs. The approval brings crucial advancements in managing this condition.

Omeros has indicated that Yartemlea is slated for market release by January 2026. This development offers a new therapeutic option for patients confronting the severe risks associated with TA-TMA after undergoing stem cell transplantation.