The FDA (Food and Drug Administration) has given Octapharma USA approval for the first-ever intravenous immunoglobulin, called Octagam 10%, to treat adult dermatomyositis. 10 out of every million people in the US live with Dermatomyositis, a rare, idiopathic autoimmune disease, who suffer with symptoms including, progressive muscle weakness, chronic muscle inflammation, skin rashes, and have a higher risk for mortality. Data from the phase 3 clinical trial (the ProDERM trial)—a randomized, double-blind, placebo-controlled trial—indicated that 78.7% of patients (95 adults) with dermatomyositis who received 2 g/kg of Octagam 10% once a month started showing a response at 16 weeks, compared with 43.8% of participants who received a placebo. In a statement by Rohit Aggarwal, MD, medical director of the Arthritis and Autoimmunity Center at the University of Pittsburgh and a member of the ProDERM study Steering Committee, said, “The study gives clinicians much more confidence in the efficacy and safety of intravenous immunoglobulin and provides valuable information about what type of patient is best suited for the treatment,”. Prior to this approval, there are no approved treatments for Dermatomyositis.

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