Exposure and Safety Information
Only one dose of RUCONEST was administered for 96% of the 224 attacks.
12 of 44 (27%) patients experienced at least one treatment emergent adverse event within 72 hours of completion of RUCONEST infusion.
TEAEs occurring in 5% of patients were nasopharyngitis, cough, fibrin D-dimer increase, and headache
The percentage of patients experiencing TEAEs did not increase with RUCONEST treatments for repeat attacks.
There were no discontinuations due to adverse events, no thrombotic or anaphylactic events, and no neutralizing anti-C1INH antibodies observed with repeat RUCONEST treatment.
Santarus and Pharming are seeking U.S. marketing approval of RUCONEST for the treatment of acute angioedema attacks in patients with HAE. The Biologics License Application filing for RUCONEST is under review by the FDA with a response expected by April 16, 2014.
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