(Reuters) – The U.S. Food and Drug Administration on Friday approved Alexion Pharmaceuticals Inc’s treatment for a second rare blood disorder, the company said.
The treatment, Ultomiris, has already been approved in the United States, Japan and the European Union to treat adults with blood disorder called paroxysmal nocturnal hemoglobinuria.
Friday’s approval allows its use in treating atypical hemolytic uremic syndrome (aHUS), a condition that causes abnormal blood clots to form in small blood vessels in the kidneys, which could result in kidney failure.
The label for the treatment carries a boxed warning, the FDA’s harshest, flagging risks of life-threatening meningococcal infections or sepsis, that have occurred in patients treated with Ultomiris.
The FDA approval is a shot in the arm for the drugmaker, which has been pushing to expand Ultomiris’ label as U.S. market exclusivity for its best-selling drug, Soliris, is being threatened. The drugmaker is pushing to convert…
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