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April 27th, 2010
Study on octagam 10% in ITP accepted for publication in "Hematology".
The manuscript entiteled "Efficacy and Safety of a New Intravenous Immunoglobulin 10% Formulation (octagam®10%) in Patients with Immune Thrombocytopenia", authored by T. Robak, C. Mainau, B. Pyringer, K. Chojnowski, J. Holowiecki, K. Warzocha, A. Dmoszynska, J. Straub and P. Imbach was accepted for publication by the journal "Hematology" and will be published soon.
The publication describes the results of a prospective, open-label, single-arm, multicenter study that assessed the efficacy, safety, and tolerability of octagam 10% in 116 subjects with newly diagnosed or chronic immune thrombocytopenic purpura (ITP) and with a platelet count of 20 x 109/L or less. Subjects ranged in age from 17 to 88; 64% were female and 36% were male.
Subjects received a 2 g/kg dose of octagam 10% administered as two daily 1 g/kg intravenous doses, given on 2 consecutive days. In a first study phase with 26 patients the maximum allowed infusion rate was 6mg/kg/min [0.06mL/kg/min], in the second study phase fifty-four (60%) of 90 subjects received Octagam 10% at the maximum infusion rate allowed (12mg/kg/min [0.12mL/kg/min]). Pre-medication to alleviate potential adverse drug reactions was only given to 1 (0.9%) of 116 patients.
Of the 115 subjects in the efficacy analysis, 92 (80%) responded to Octagam 10% with a rise in platelet counts to at least 50 x 109/L within 7 days after the first infusion.
In 64 of the 85 subjects (75%) who had bleeding at baseline, the hemorrhages had completely resolved by Day 7. A decrease in the severity of hemorrhage from baseline to Day 7 was observed in 74 (87%) subjects: 38 of 45 subjects (84%) with chronic ITP and 36 of 40 (90%) subjects with newly-diagnosed ITP.
octagam®10% was well tolerated, even at the maximum infusion rate of 0.12 mL/kg/min and without premedication that could have masked adverse reactions.
About Octagam®10% :
Octagam®10% is a liquid, 10% (100 mg/mL) immune globulin (human) solution for intravenous administration (IVIG) which is currently registered in European countries and expected to be launched in the US later this year. It is the 10% version of Octagam® (50 mg/mL) which was first launched in 1995 and is currently sold in about 60 countries worldwide, including the USA and the EU.
About Octapharma AG:
Octapharma, a biopharmaceutical company, was founded in 1983. Its mission is to work for the safe and optimal usage of human proteins. Octapharma products are state-of-the-art within treatment of immune diseases, haemophilia, volume expansion and plasma transfusions. Octapharma’s turnover in 2009 was EUR 1,009 million. Octapharma is a privately held company with headquarters in Lachen, Switzerland, and employs 4,000 people worldwide.
© Octapharma AG, 2010
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