FDA Approval of YARTEMLEA for TA-TMA

YARTEMLEA(narsoplimab-wuug) has received FDA approval for the treatment of transplant-associated thrombotic microangiopathy (TA-TMA) in patients aged 2 years and older, making it the first and only therapy indicated for this condition.

Until now, TA-TMA care depended on supportive measures, immunosuppression modification, and off-label pharmacologic strategies without a regulatory-approved, disease-targeted agent.

YARTEMLEA achieved a 61% complete response in TA-TMA study and 68% in the expanded-access program among evaluable patients.

YARTEMLEA has no Boxed Warning and no REMS requirement, but serious infections and other adverse reactions have occurred in some patients. In the TA-TMA study, serious adverse reactions occurred in 61% of YARTEMLEA-treated patients.