Mallinckrodt moves closer to US approval with terlipressin

UK-headquartered Mallinckrodt (NYSE: MNK) has initiated the rolling submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for terlipressin in hepatorenal syndrome type 1 (HRS-1).

This approach allows the company to submit portions of the regulatory application to the FDA as they are completed, and Mallinckrodt has said that it expects the filing to be fully submitted within months.

HRS-1 is an acute and life-threatening syndrome involving acute kidney failure in people with cirrhosis. The condition has a median survival time of less than two weeks and greater than 80% mortality within three months if left untreated.