Mallinckrodt’s Phase III Kidney Failure Trial Hits Primary Endpoint
Executive Summary
The data position Mallinckrodt to file for US FDA approval of terlipressin early next year. Mallinckrodt thinks the drug could generate sales of $300m a year, helping it to mitigate its challenges.
You may also be interested in...
Terlivaz Approved By FDA As Mallinckrodt Seeks To Advance New Business Strategy
Terlivaz is the first product approved to improve kidney function in adults with hepatorenal syndrome (HRS). The approval is a milestone in a long regulatory road for the drug.
US FDA Advisory Cmte. To Evaluate Terlipressin's Clinical Outcomes, Risk Of Respiratory Failure
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.
Cosmetic And Personal Care Trademark Review: 16 April
Personal care and cosmetic product trademark filings compiled from the Official Gazette of the US Patent and Trademark Office, Class 3.