Alex­ion clinch­es aHUS ap­proval for Ul­tomiris as the clock ticks on Soliris con­ver­sion

Alex­ion has racked up a sec­ond ap­proval for Ul­tomiris, the suc­ces­sor ther­a­py to Soliris, as its main­stay block­buster ther­a­py faces a patent re­view process that could dras­ti­cal­ly short­en its patent ex­clu­siv­i­ty.

The FDA OK for atyp­i­cal he­molyt­ic ure­mic syn­drome (aHUS) on Fri­day was wide­ly ex­pect­ed af­ter Alex­ion post­ed a full slate of pos­i­tive Phase III da­ta in Jan­u­ary. But reg­u­la­tors al­so flagged con­cerns about se­ri­ous meningo­coc­cal in­fec­tions, slap­ping a black box warn­ing on the la­bel and man­dat­ing a REMS.

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