Alexion Announces Positive Top-Line Results From Phase 3 Study Of ULTOMIRIS? (Ravulizumab-Cwvz) In Complement Inhibitor-Na?ve Patients With Atypical Hemolytic Uremic Syndrome (AHUS)
-- Study met primary objective of complete thrombotic microangiopathy (TMA) response --
-- Regulatory submission in the U.S. planned for first half of 2019, followed by the European Union and Japan --
- reduced thrombocytopenia, as measured by normalization in platelet count, in 83.9 percent of patients (95% CI [73.4%, 94.4%]),
- reduced hemolysis (the destruction of red blood cells), as measured by normalization in lactate dehydrogenase (LDH) level, in 76.8 percent of patients (95% CI [64.8%, 88.7%]) and
- improved kidney function, as measured by = 25 percent improvement in serum creatinine level from baseline, in 58.9 percent of patients (95% CI [45.2%, 72.7%]). For patients on dialysis at enrollment, baseline was established after they had come off dialysis.
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