FDA Orphan Drug Approval: Octapharma’s Octagam® 10% Receives 7 Years of Market Exclusivity for Adult Dermatomyositis

Octapharma USA today announced the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) has awarded seven years of marketing exclusivity for Octagam^® 10% [Immune Globulin Intravenous (Human)], the first and only intravenous immunoglobulin (IVIg) to be indicated for the treatment of adult dermatomyositis (DM).

“The FDA approval of orphan drug status for Octagam^® 10% to treat adults with DM should encourage patients to ask their physicians about the therapy because they no longer have to rely on treatments that have not been specifically evaluated by the FDA for DM,” said Octapharma USA President Flemming Nielsen. “We expect that Octagam^® 10% may become the first treatment option for the vast majority of adults with DM given the outstanding results from the ProDERM clinical trial.”

Dermatomyositis is a rare idiopathic autoimmune disorder of unknown cause affecting approximately 10 out of every million U.S. residents. Patients commonly suffer from skin rashes, chronic muscle inflammation and progressive muscle weakness, usually affecting adults in their late 40s to early 60s and children between the ages of 5 and 15. Complications include difficulty swallowing, aspiration pneumonia, breathing problems and calcium deposits on muscles, skin and connective tissues.^{1, 2, 3, 4}

The FDA grants orphan drug status to novel therapies that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 U.S residents. After market approval for the orphan designation, the FDA/OOPD will award seven years of market exclusivity.

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