IVIG receives FDA approval for dermatomyositis
medwireNews: The US FDA has approved intravenous immunoglobulin (IVIG) for the treatment of dermatomyositis in adults.
Previously approved for chronic immune thrombocytopenic purpura, IVIG may now be used for dermatomyositis at a dose of 2 g/kg divided into equal doses given over 2–5 consecutive days once every 4 weeks.
This approval is based on results from the phase 3 ProDERM trial, which demonstrated significantly higher treatment response rates among patients with active dermatomyositis who were treated with IVIG versus placebo.
The label for IVIG contains a boxed warning for thrombosis, renal dysfunction, and acute renal failure.
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