The immunoglobulin treatment for dermatomyositis from Octapharma has been granted approval in the USA and Europe. According to a press release, this was received following the outcome of a large-scale study conducted by the world-renowned German contract research organization ProDERM. This demonstrated the efficacy of octagam 10% and found that the intravenous treatment was generally well tolerated. The study enrolled 95 adults from 36 sites in 10 countries.
Dermatomyositis is a rare disease that affects skeletal muscle, skin and internal organs. The mortality rate is around 30 percent in the first two years. Prior to the ProDERM study findings, no therapy had been approved in the USA or Europe for the treatment of dermatomyositis based on randomized clinical trials. Flemming Nielsen, President of Octapharma USA, said that publication of the study in the New England Journal of Medicine was “an exciting milestone” for all involved.
Rohit Aggarwal, Medical Director of the Arthritis and Autoimmunity Center at the University of Pittsburgh School of Medicine and chair of the ProDERM study Steering Committee, spoke of the ProDERM study and its publication in the New England Journal of Medicine marking “a clear turning point in the management of patients with this disease”. Physicians are now “able to offer patients an effective treatment option with proven efficacy, safety and tolerability”.