RHUCIN treatment was well tolerated in the studies. No patient was discontinued due to an adverse reaction. Adverse events occurred less frequently in the RHUCIN groups (27 adverse events in 7 patients treated with 100 U/kg and 6 adverse events in 4 patients of the 50 U/kg group) than in the placebo group (33 adverse events in 14 patients). Adverse events that were assessed as related to study treatment for patients exposed to RHUCIN included headache and vertigo; adverse events that were assessed as related to patients receiving placebo were headache, injection site swelling, epistaxis and hypotension. One serious adverse event occurred in the 100 U/kg (31 days following treatment) and three in the placebo group. None of the serious adverse events were considered by the investigator to be possibly, probably or definitely related to study drug.

Lead author Bruce Zuraw, M.D., said, "The publication of the results from these randomized controlled trials is an important step in educating the medical community about recombinant human C1INH for HAE patients with acute angioedema." Dr. Zuraw is a leading authority on HAE and is Professor of Medicine and Chief, Section of Allergy & Immunology in the Department of Medicine, University of California, San Diego and Research Scientist at the Veterans Medical Research Foundation, San Diego, CA.

Santarus recently licensed exclusive rights from Pharming Group NV to commercialize RHUCIN in North America for the treatment of acute attacks of angioedema in patients with HAE and other future indications.

Source : Santarus, Inc.