2:36AM Santarus and Pharming announce new data from open-label repeat treatment study with RUCONEST (SNTS) 23.22 : Santarus and Pharming Group NV announce that new data from an open-label extension of the pivotal Phase III clinical study with RUCONEST. The median time in minutes to onset of symptom relief following treatment as measured by patient responses to a Treatment Effect Questionnaire for the first five repeat attacks ranged from 62.5 (48, 90) to 134.0 (75, 150) and across all attacks was a median of 75.0 (69, 89). The median (95% CI) time in minutes to minimal symptoms (first three attacks per patient) as measured by a TEQ ranged from 243 (76, 1440) to 304 (150, 719) and for all assessed attacks was 303 (211, 367).
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.
