Release Date: 01-Oct-2021
U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) has awarded seven years of marketing exclusivity for Octagamandreg; 10% [Immune Globulin Intravenous (Human)], the first and only intravenous immunoglobulin (IVIg) indicated to treat adult dermatomyositis (DM). Octagam 10% is an immune globulin intravenous (human) liquid preparation indicated for the treatment of:
The FDA's orphan-drug program gives special status to drugs and biologics for diseases and disorders that affect fewer than 200,000 people in the U.S and it also gives several benefits, like tax credits for qualified clinical trials, potential seven years of market exclusivity after approval and exemption from user fees.
The FDA approval is based on the results of ProDERM, a pivotal randomized clinical trial and the first study to evaluate the long term efficacy and safety of 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., and is the largest study to evaluate intravenous immunoglobulin as a treatment option for DM.