Octagam 10% Approved for Adult Dermatomyositis
Credit: Octapharma.
The Food and Drug Administration (FDA) has approved Octagam
® 10% (immune globulin intravenous [human]) for the treatment of adult dermatomyositis, a rare immune-mediated inflammatory disease.
The approval was based on data from the prospective, double-blind, randomized, placebo-controlled phase 3 ProDERM study (ClinicalTrials.gov Identifier: NCT02728752), which evaluated the efficacy and safety of Octagam 10% in 95 adults with dermatomyositis. Patients were randomly assigned to receive either Octagam 10% or placebo intravenously (IV) every 4 weeks during the initial 16 week period, followed by a 24-week open-label extension phase during which all patients received Octagam 10% every 4 weeks. The primary endpoint was the proportion of responders at week 16, defined as a patient with an increase of at least 20 points on the Total Improvement Score (TIS).