Glassia Designated Orphan Drug for Graft-Versus-Host Disease
Kamada announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to Glassia (alpha1-proteinase inhibitor [human]) for the treatment of Graft-versus-host disease (GVHD).
Preliminary human and animal studies indicate that Glassia may be able to treat and reduce the severity of GVHD. Currently, Glassia is being studied in a Phase 1/2 clinical study. The Phase 1/2 study is evaluating 24 GVHD patients with inadequate response to steroid treatment following allogeneic bone-marrow stem cell transplant. The patients are enrolled into four dose cohorts, in which they receive up to eight doses of Glassia. Interim data from this study is expected by the end of this year.
Glassia is already indicated for chronic augmentation and maintenance therapy in adults with clinically evident emphysema due to severe congenital deficiency of alpha1-antitrypsin deficiency.
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