FDA shoots down Mallinck­rodt's re­demp­tion at­tempt, spurns rare kid­ney dis­ease drug for a sec­ond time

What­ev­er hope Mallinck­rodt had fol­low­ing a nar­row rec­om­men­da­tion by the FDA ad­vi­so­ry com­mit­tee to ap­prove ter­li­pressin has been dashed by a firm re­jec­tion.

The com­plete re­sponse let­ter stabbed right through the UK drug­mak­er’s case for the drug, as reg­u­la­tors are ask­ing for “more in­for­ma­tion to sup­port a pos­i­tive risk-ben­e­fit pro­file for ter­li­pressin” as a treat­ment of the rare kid­ney dis­ease known as he­pa­tore­nal syn­drome type 1, or HRS-1.

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