Policy & Regulation
Octapharma wins FDA approval for Octagam 10% for dermatomyositis based on positive international, multi-centre ProDERM study
21 July 2021 -

Human protein manufacturer Octapharma USA reported on Tuesday the receipt of approval for the first and only intravenous immunoglobulin (IVIg) Octagam 10% for the treatment of adult dermatomyositis from the US Food and Drug Administration (FDA).

Dermatomyositis is a rare idiopathic autoimmune disorder of unknown cause and the patients suffer from skin rashes, chronic muscle inflammation and progressive muscle weakness, usually affecting adults in their late 40s to early 60s and children between five and 15.

The company said Octagam 10% [Immune Globulin Intravenous (Human)] is an immune globulin intravenous (human) liquid preparation.

This FDA approval is based on the results of the company's ProDERM , a pivotal randomized clinical trial and the first study to evaluate the long term efficacy and safety of intravenous immunoglobulin (IVIg) for adults with dermatomyositis. The prospective, double-blind, placebo-controlled Phase III clinical trial enrolled 95 patients at 36 sites globally, including 17 sites in the U.S.

According to the company, the patient response to treatment was measured using the 2016 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) myositis response criteria. In the initial 16-week phase, about 78.7% of patients receiving Octagam 10% responded positively to treatment as compared to 43.8% of those receiving placebo.