Octagam 10% approved for adult dermatomyositis
The FDA has approved intravenous immunoglobulin Octagam 10% for the treatment of adult dermatomyositis, Octapharma USA announced in a press release.
A rare idiopathic autoimmune disease, dermatomyositis affects approximately 10 out of every million people in the U.S. and causes skin rashes, chronic muscle inflammation and progressive muscle weakness.
Octagam 10% was effective in 78.7% of patients with dermatomyositis during an initial 16-week double-blind, placebo-controlled phase of the ProDERM clinical trial. During a 24-week open-label extension phase of the trial, patients in the placebo group who switched to the active group experienced a similar response rate at week 40, according to the release.
“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,” Flemming Nielsen, Octapharma USA president, said in the release. “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.”