Japan’s Ministry of Health, Labour and Welfare has approved Alexion Pharmaceuticals' (NASDAQ:ALXN) Ultomiris (ravulizumab) for atypical hemolytic uremic syndrome (aHUS), for use in adults and children.
Ultomiris is a long-acting C5 inhibitor for aHUS and is administered every other month for adults and children (20 kg or more) and monthly for children (<20 kg).
Atypical HUS is an ultra-rare life-threatening disorder characterized by renal failure and the formation of blood clots in the small blood vessels throughout the body.
Recently, European advisory recommended the marketing authorization in the European Union for a new 100 mg/mL intravenous advanced formulation of Ultomiris.
https://seekingalpha.com/news/3617307-alexion-ultomiris-okd-in-japan
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