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Omeros’ Narsoplimab Meets its Pivotal Trial Primary Endpoint – Statistical Analysis Shows Survival Superiority Over External Control in Patients with TA-TMA
Omeros (OMER) announced successful results from its narsoplimab pivotal trial for treating transplant-associated thrombotic microangiopathy (TA-TMA). The primary statistical analysis showed that patients treated with narsoplimab had an over 3-fold reduction in mortality risk (hazard ratio = 0.32) compared to untreated patients in an external control group.
The study compared 28 narsoplimab-treated TA-TMA patients against more than 100 similar high-risk patients from a stem cell transplant registry. The results were highly statistically significant (p < 0.00001). Based on these positive outcomes, Omeros will resubmit its Biologics License Application (BLA) to FDA, aiming to make narsoplimab the first approved treatment for TA-TMA.
The study compared 28 narsoplimab-treated TA-TMA patients against more than 100 similar high-risk patients from a stem cell transplant registry. The results were highly statistically significant (p < 0.00001). Based on these positive outcomes, Omeros will resubmit its Biologics License Application (BLA) to FDA, aiming to make narsoplimab the first approved treatment for TA-TMA.
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