05:08 AM EDT, 03/26/2024 (MT Newswires) -- argenx (ARGX) said Tuesday that Japan's Ministry of Health, Labour and Welfare approved Vyvgart, or efgartigimod alfa, for intravenous use in adults with primary immune thrombocytopenia, an autoimmune disorder.
The immunology company said the approval follows the results of a phase 3 trial, which met its primary endpoint.
The 24-week study demonstrated a higher proportion of chronic thrombocytopenia patients achieved a "sustained platelet count response compared to placebo," the company said.
The medication was "well-tolerated" in the trial, and its "observed safety and tolerability profile was consistent with previous clinical trials," the company added.