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Regulatory Focus™ > News Articles > 2020 > 10 > FDA Approvals Roundup: New formulation for Ultomiris

FDA Approvals Roundup: New formulation for Ultomiris

Posted 14 October 2020 | By Renee Matthews 

FDA Approvals Roundup: New formulation for Ultomiris

New formulation
Ultomiris gets new formulation for blood-related disorders 
Alexion’s Ultomiris (ravulizumab-cwvz injection) has been approved as a 100 mg/mL formulation for treating adults with paroxysmal nocturnal hemoglobinuria (PNH) and for atypical hemolytic uremic syndrome (aHUS) for adults and children aged one month or older. 

The new formulation of the complement inhibitor will cut annual infusion time by about 60%, or six hours, compared with the 10 mg/mL dose while retaining comparable safety and efficacy. The shorter infusion time will improve patients’ treatment-related quality of life.  

PNH is a rare blood disorder characterized by destruction of the red blood cells, causing debilitating symptoms and complications, such as fatigue, anemia, or thrombosis, which can result in organ damage and premature death. Atypical HUS is marked by progressive injury to vital organs, especially the kidneys, as a result of damage to blood vessel walls and blood clots. 


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