New High Purity Immunoglobulin Enters Phase III in Europe and the US
Octapharma AG announced the start of the first of a series of phase III studies for its new 10% high purity intravenous immunoglobulin (IVIG). The study will investigate the efficacy and safety of this novel immunoglobulin in the treatment of primary immune deficiency and, together with results from additional upcoming studies, will support its regulatory filing inEuropeand the US.
Commenting on the start of the study, Kim Björnstrup, Deputy Chairman of Octapharma Group said, "The development of our novel 10% IVIG is part of our ongoing commitment to invest in the development of protein based immunotherapies and in particular in IgG preparations. For 25 years, our cutting-edge research programme has sought to develop new biological entities tailored specifically around the needs of clinicians and patients - delivering improved quality of life for patients and ease of delivery and management for hospitals."
The Phase III study in primary immune deficiency represents the start of a series of planned studies to investigate Octapharma's new 10% IVIG for a range of neurologic and haematological conditions including idiopathic thrombocytopenic purpura (ITP), Guillain-Barré syndrome (GBS) and Kawasaki disease and chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).
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