FDA Approves First and Only IVig Treatment for Dermatomyositis

The US Food and Drug Administration (FDA) has approved the use of Octagam 10%—the first and only intravenous immunoglobulin (IVig) for the treatment of dermatomyositis.

The ProDERM Phase 3 clinical trial to evaluate the long-term safety and efficacy of IVig included 95 adult patients with dermatomyositis across 36 global sites, including 17 in the US. During the 16-week phase of the trial, most patients (78.7%) receiving Octagam10% experienced a positive response to treatment compared to those (43.8%) receiving a placebo. Participants receiving the placebo were switched to IVig treatment and achieved a similar response rate by week 40 as the Octagam10% group achieved at week 16.

—Angelique Platas

Reference

FDA approves octapharma’s octagam® 10% for adult dermatomyositis. Press Release. July 20, 2021. Accessed July 21, 2021. https://www.businesswire.com/news/home/20210720005999/en/FDA-Approves-Octapharma%E2%80%99s-Octagam%C2%AE-10-for-Adult-Dermatomyositis