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.
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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.
Heading into an advisory committee review, agency suggests belantamab’s risks of keratopathy and other ocular issues have not been fully characterized and questions whether the proposed mitigation measures, including dosing modifications, are adequate.
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.