Mallinckrodt’s Kidney Failure Drug Narrowly Wins Backing of FDA Panel
Summary
An experimental Mallinckrodt Pharmaceuticals drug for a rare type of kidney failure has won the support of an FDA advisory panel by the thinnest of margins. The committee of mostly physicians concluded that the benefits of the drug, terlipressin, outweigh its safety risks as a treatment for hepatorenal syndrome type 1 (HRS-1), and panelists voted 8-7 on Wednesday to recommend regulatory approval. Terlipressin is an engineered version of vasopressin, a hormone that plays a role in blood pressure regulation and kidney function. FDA reviewers noted that the percentage of patient deaths was higher in the terlipressin arm compared with the placebo group. Complications associated with respiratory failure, sepsis, and septic shock were also reported at a higher rate in the terlipressin group.
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