So­bi's high-pri­or­i­ty rare dis­ease drug runs in­to a wall at EMA

The EMA has re­buffed Swe­den-based So­bi’s pitch for ema­palum­ab, shoot­ing down high hopes for a $568 mil­lion drug.

So­bi said it will re­quest a re-ex­am­i­na­tion by the reg­u­la­tors, which will kick off a new re­view process that should pro­duce a de­ci­sion by the end of the year. The an­ti­body is de­signed to treat pri­ma­ry he­mo­phago­cyt­ic lym­pho­his­ti­o­cy­to­sis in chil­dren un­der 18 years old by tar­get­ing in­ter­fer­on gam­ma (IFNγ).

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