April 28, 2020
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FDA accepts new drug application for drug to treat hepatorenal syndrome type 1

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The FDA has accepted a new drug application for terlipressin, a medication that could be used to treat hepatorenal syndrome type 1, according to a press release from biopharmaceutical company Mallinckrodt.

Hepatorenal syndrome [HRS-1] consists of acute kidney failure in people with cirrhosis and has an 80% or greater mortality rate within 3 months if not treated, according to the release.

Due to the need for a pharmaceutical option to treat such a condition, Mallinckrodt conducted a long-term study, known as the Confirm trial, which included 300 patients with HRS-1. The release stated that its positive phase 3 results led, in part, to the acceptance of the NDA.

The FDA had already granted fast track designation to the drug in 2005.

“We are pleased that we received filing acceptance of our NDA submission,” Steven Romano, MD, executive vice president and chief scientific officer for the company, said in the release. “This is an important milestone in our clinical development program for terlipressin to address a critically high unmet need for patients with HRS-1 and their physicians, who historically have had limited treatment options. We look forward to working with the agency during their review of our regulatory package.”