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Octagam 10% Approved for Adult Dermatomyositis


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). ....

Octapharma Octagam , Rohit Aggarwal , University Of Pittsburgh School Medicine , Drug Administration , Octapharma United States Inc , Autoimmunity Center , Total Improvement Score , Cutaneous Dermatomyositis Disease Area , Severity Index , Medical Director , Pittsburgh School , Accessed July , பல்கலைக்கழகம் ஆஃப் பிட்ஸ்பர்க் பள்ளி மருந்து , மொத்தம் முன்னேற்றம் மதிப்பெண் , தீவிரம் குறியீட்டு , மருத்துவ இயக்குனர் , பிட்ஸ்பர்க் பள்ளி ,