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news.Lev Pharmaceuticals has reported positive results from a Phase III study examining the efficacy and safety of prophylactic use of its C1 inhibitor replacement therapy, Cinryze, in patients with hereditary angioedema.
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The multi-center study observed the effect of Cinryze on the frequency of hereditary angioedema (HAE) attacks. The primary endpoint was met with a 52% reduction in the number of attacks in the Cinryze group (p<0.0001). Secondary endpoints in the study also showed highly significant differences in favor of Cinryze, including a 66% reduction in days of swelling (p<0.0001) and decreases in the average severity of attacks (p=0.0008) and average duration of attacks (p=0.0004). No safety issues were identified. Joshua Schein, CEO of Lev, said: "We are pleased that this study corroborates the years of clinical evidence supporting the prophylactic use of C1 inhibitor replacement therapy in European patients with hereditary angioedema. With this validation, we hope to secure FDA approval so we can begin providing this life-saving therapy to the thousands of US patients who need it."