The time to beginning of symptom relief was the primary endpoint of the study that assessed the safety and efficacy profile of Ruconest (recombinant human C1 esterase inhibitor) 50 U/kg.
Santarus research and development executive vice president Wendell Wierenga said, "These positive results are consistent with the efficacy data previously reported from two smaller randomized, controlled clinical studies with RUCONEST in patients with HAE, and we believe the results provide strong support for our proposed dosing regimen of 50 U/kg in treating acute attacks of HAE."
The intent-to-treat population between Ruconest and placebo demonstrated a considerable difference in the time to beginning of symptom relief.
Median time of 90 minutes was observed in Ruconest patients to beginning of symptom relief and 152 minutes for placebo patients.
Ruconest was generally well tolerated while four Ruconest patients reported adverse events such as sneezing, procedural headache, back pain, skin burning sensation, an increase in fibrin D-dimer and lipoma within 72 hours of receiving the medication.
Pharming chief operations officer Bruno Giannetti said the company is looking forward to working with Santarus to prepare and submit the biologics license application for Ruconest to the FDA in the first half of 2013.
"We anticipate that additional data from this Phase III study will be presented at an appropriate medical meeting in 2013," Giannetti added.