Santarus, Inc. (SNTS) and Pharming Group NV (PHGUF.PK) said that retrospective analyses of integrated efficacy data and immuno-safety data were presented in two oral presentations at the 2011 Biennial Meeting of the World Allergy Congress in Cancun, Mexico on December 6, 2011.
According to the company, the data analyzed are from placebo-controlled and open-label clinical studies conducted with the investigational drug RHUCIN in patients with hereditary angioedema, or HAE.
The first oral presentation was titled Clinical Efficacy of Recombinant Human C1 Inhibitor in Patients with Acute Hereditary Angioedema Attacks. This integrated efficacy dataset included 155 HAE patients treated for 424 angioedema attacks with 100 U/kg, 50 U/kg and 2100 U of RHUCIN, including patients treated for repeated attacks. Median time to the primary endpoint of onset of symptom relief for attacks treated with 100 U/kg, 50 U/kg and 2100 U of RHUCIN were 66, 60 and 61 minutes, respectively, compared with 495 minutes in the placebo-treated group.
The second oral presentation was titled Immuno-safety of Recombinant Human C1 Inhibitor in Patients with Hereditary Angioedema: An Integrated Analysis. Data from this presentation were previously discussed, the companies noted.
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