The FDA granted approval to Alexion’s biologic Ultomiris (ravulizumab-cwvz) for atypical hemolytic uremic syndrome (aHUS).
The agency’s greenlight approves the drug for treating adult and pediatric aHUS patients one month or older. It marks the drug’s first pediatric approval.
The foodborne illness can progressively damage vital organs, primarily the kidneys, and lead to organ failure and death.
Patients frequently require intensive care, including dialysis. Timely diagnosis and treatment are important due to the poor prognosis for many aHUS patients.