FDA orphan drug approval: Octapharma’s Octagam 10% receives 7 years of market exclusivity for adult dermatomyositis

Octapharma

30 August 2021 - Octagam 10% expected to become the first treatment option for adults with rare immune-mediated inflammatory disease.

Octapharma USA today announced the U.S. FDA Office of Orphan Products Development has awarded seven years of marketing exclusivity for Octagam 10% [immune globulin intravenous (human)], the first and only intravenous immunoglobulin to be indicated for the treatment of adult dermatomyositis.

Read Octapharma press release

Michael Wonder

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Michael Wonder