Santarus Inc. (SNTS) and Pharming Group NV (PHGUF.OB) reported that their pivotal Phase III trial to assess the safety and efficacy of the investigational drug RUCONEST 50 U/kg for the treatment of acute attacks of angioedema in patients with Hereditary Angioedema or HAE met the primary endpoint of time to beginning of symptom relief.
According to Santarus, a statistically significant difference in the time to beginning of symptom relief was observed in the intent-to-treat population between RUCONEST and placebo; the median time to beginning of symptom relief was 90 minutes for RUCONEST patients and 152 minutes for placebo patients.
RUCONEST was generally well tolerated in this Phase III study and the frequency of patients experiencing at least one treatment emergent adverse event in the RUCONEST treated group was less than in the placebo group.
Pharming conducted study 1310 with RUCONEST under a Special Protocol Assessment agreement with the FDA, and the trial is intended to support the submission of a BLA in the U.S. In Study 1310, RUCONEST was evaluated for the treatment of acute attacks of angioedema in patients with HAE in an international, multicenter, randomized, placebo-controlled Phase III trial comparing a single IV infusion of 50 U/kg of RUCONEST to a saline control with a primary endpoint of time to beginning of symptom relief.
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