US FDA approves Omeros’ drug to treat dangerous transplant complication
The U.S. Food and Drug Administration has approved Omeros’ drug for a dangerous transplant complication, marking the first treatment to be greenlit for the condition, the company said on Wednesday.
The drug, branded as Yartemlea, is used to treat a condition known as transplant-associated thrombotic microangiopathy (TA-TMA), a serious complication that can develop after stem cell transplants, particularly those that use healthy cells from a donor.
The disease occurs due to damaged blood vessels during or after a stem cell transplant as a result of an overactive immune system, causing inflammation. This leads to tiny blood clots that can harm organs such as the kidneys, sometimes causing life-threatening problems.
A stem cell transplant replaces damaged or unhealthy blood-making cells with healthy ones from either the patient or a donor, aiding the body to generate new cells — vital for treating diseases and enabling a robust immune response.
Omeros said it expects the treatment to be available on the market by January 2026.
The company did not immediately respond to a Reuters request for a comment on Yartemlea’s pricing.
