FDA grants Octapharma orphan drug designation for Octagam 10%

The U.S. FDA has granted Octapharma with orphan drug designation for Octagam 10%.

Octagam 10% is an immune globulin intravenous (human) liquid for the treatment of dermatomyositis.

Octapharma USA President, Flemming Nielsen said that they are pleased that the FDA has granted orphan drug designation to Octagam 10% for the treatment of dermatomyositis. 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.

Dermatomyositis is a rare acquired disorder characterized by chronic inflammatory and degenerative changes of the muscles and skin. 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 and its cause of is unknown. There is no cure for dermatomyositis.