The US Food and Drug Administration (FDA) has granted Octapharma USA orphan drug designation for Octagam Immune Globulin Intravenous (Human) 10% Liquid for the treatment of dermatomyositis, a rare acquired disorder characterized by chronic inflammatory and degenerative changes of the muscles and skin.

“We are pleased that the FDA has granted orphan drug designation to Octagam 10% for the treatment of dermatomyositis,” said Octapharma USA President Flemming Nielsen. “Octapharma is committed to providing patients with life-enhancing and life-saving therapies. Helping patients with chronic diseases such as dermatomyositis maximize their quality of life is central to Octapharma’s mission and culture.”

The cause of dermatomyositis is unknown. The disorder’s main symptom is a skin rash that precedes or accompanies progressive muscle weakness. The disease is most common in children between ages 5 and 15 and adults in their late 40s to early 60s, but can occur at any age. There is no cure for dermatomyositis. The estimated incidence of dermatomyositis is 9.63 cases per million population.

The FDA Orphan Drug Designation programme provides orphan status to drugs and biologics, which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the US, or that affect 200,000 or more people, but where sales are not expected to recover the costs of research and development of the product.