Imlifidase successfully meets primary endpoint in pivotal US Phase 3 ConfIdeS trial in kidney transplantation
At 12 months, mean eGFR was 51.5 mL/min/1.73m2 in the imlifidase arm versus 19.3 mL/min/1.73m2 in the control arm with a statistically significant and clinically meaningful difference of 32.2 mL/min/1.73m2 ( p<0.0001) Imlifidase was generally well tolerated with a safety profile consistent with previous clinical trial experience Submission of a Biologic License Application (BLA) under accelerated approval pathway […]

