US FDA Advisory Cmte. To Evaluate Terlipressin's Clinical Outcomes, Risk Of Respiratory Failure
Executive Summary
Mallinckrodt's drug to treat hepatorenal syndrome met its primary endpoint of HRS reversal but FDA wants reassurance that this surrogate endpoint translates into a treatment effect on clinical outcomes. A greater incidence of respiratory failure in those receiving terlipressin "remains a significant safety concern," the agency says.
You may also be interested in...
Mallinckrodt’s Terlipressin Narrowly Clears US FDA Panel As Need For Liver Treatment Outweighs Safety Worries
Advisory committee votes 8-7 to recommend approval for terlipressin to treat HRS-1 but is critical of Mallinckrodt’s plan to mitigate the risk of respiratory failure.
GlaxoSmithKline Survives Technical Woes To Win US FDA Panel Nod For Belantamab
Benefits of the BCMA-directed antibody-drug conjugate outweigh its ocular risks in heavily pretreated multiple myeloma patients, Oncologic Drugs Advisory Committee says at the conclusion of a virtual meeting beset by technical problems.
Mallinckrodt’s Hepatorenal Syndrome Drug Terlipressin Gets A Virtual AdComm
US FDA cardiovascular and renal drugs panel will weigh approvability of the vasopressin analog during a nine-hour, online meeting 15 July; terlipressin was the focus of a 2009 complete response letter but met its primary endpoint in the recent CONFIRM trial.