Octagam for Adult DM (IMAGE)
Caption
The U.S. Food and Drug Administration has granted approval to Octapharma USA for Octagam® 10% [Immune Globulin Intravenous (Human)], the first and only intravenous immunoglobulin (IVIg) to be indicated for the treatment of adult dermatomyositis, a rare immune-mediated inflammatory disease. The FDA approval is based on the results of ProDERM (ClinicalTrials.gov Identifier: NCT02728752), a pivotal randomized clinical trial and the first study to evaluate the long term efficacy and safety of intravenous immunoglobulin (IVIg) for adults with dermatomyositis.
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Octapharma
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