Alexion wins priority review for Ultomiris' aHUS indication; FDA expands approval of Vertex's Symdeko
→ Alexion $ALXN has scored a speedy review for Ultomiris for patients with atypical hemolytic uremic syndrome (aHUS) after posting positive data from a pivotal study in January. The drug is the rare disease company’s shot at protecting its blockbuster blood disorder franchise that is currently centered around its flagship drug, Soliris, which is a complement inhibitor typically administered every two weeks. Ultomiris has a similar mechanism of action but requires less-frequent dosing — every eight weeks. The decision date has been set to October 19. Late last year, Ultomiris secured approval for nocturnal hemoglobinuria (PNH) patients.
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