Octapharma gets Octagam 10% FDA approval for adult dermatomyositis
Octapharma USA has secured approval for Octagam 10% [Immune Globulin Intravenous (Human)] from the US Food and Drug Administration (FDA) for the treatment of adult dermatomyositis.
The company, which is a subsidiary of Swiss human protein manufacturer Octapharma, said that Octagam 10% is the first and only intravenous immunoglobulin (IVIg) to have been indicated by the FDA for the rare immune-mediated inflammatory disease.
Octagam 10% was approved by the FDA in 2014 for the treatment of chronic immune thrombocytopenic purpura (ITP).
Its FDA approval for adult dermatomyositis was driven by the findings of the phase 3 ProDERM clinical trial, which assessed the long term efficacy and safety of the intravenous immunoglobulin in adults with dermatomyositis.
During the initial 16-week phase of the late-stage trial, 78.7% of patients subjected to Octagam 10% responded positively to treatment, in comparison to 43.8% of those who were given placebo.
The ProDERM clinical trial featured 95 patients and was held at 36 sites in different parts of the world, of which 17 sites were in the US.
Flemming Nielsen – Octapharma USA President said: “The FDA approval of Octagam 10% as a safe and effective treatment for dermatomyositis in adults is exciting news for patients who previously relied on unapproved treatments.
“Octapharma is committed to providing life-saving and life-enhancing therapies for patients with rare diseases. We look forward to partnering with patient organizations and the medical community to develop educational and other support programs that will serve dermatomyositis patients.”