FDA approves Ultomiris for children with paroxysmal nocturnal hemoglobinuria


Sumary of FDA approves Ultomiris for children with paroxysmal nocturnal hemoglobinuria:

  • The FDA approved ravulizumab-cwvz injection to treat children aged 1 month and older with paroxysmal nocturnal hemoglobinuria..
  • Researchers evaluated the efficacy of ravulizumab-cwvz (Ultomiris, Alexion) — previously approved for adults — among children in a 26-week study that enrolled 13 patients aged 9 to 17 years, eight of whom previously had received eculizumab (Soliris, Alexion)..
  • Patients received a first dose of ravulizumab-cwvz followed by maintenance treatment 15 days later, with treatment continuing every 8 weeks for patients weighing at least 44 pounds and every 4 weeks for those weighing less than 44 pounds..
  • Sixty percent of patients who had not previously received complement inhibitors avoided a blood transfusion, a secondary endpoint, through week 26..
  • Ravulizumab-cwvz is only available through a risk evaluation and mitigation strategy due to the risk for meningococcal infections and other infections…

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