LEV PHARMACEUTICALS RECEIVES FAST-TRACK DESIGNATION FOR C1-INH

Lev Pharmaceuticals' lead investigational product, C1-esterase inhibitor (C1-INH), has been granted fast-track status by the FDA for the treatment of hereditary angioedema (HAE).

Lev Pharmaceuticals initiated a Phase III trial of C1-INH in the first quarter of this year. The first part of the study, which is ongoing, is designed to examine the efficacy and safety of C1-INH in the treatment of acute attacks in HAE. The second part of the Phase III study is specifically examining the ability of C1-INH to prevent such inflammatory attacks.