FDA grants approval of Terlivaz injection to treat patients with hepatorenal syndrome
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The FDA has announced approval of Terlivaz, a terlipressin injection formulation by Mallinckrodt plc., to treat patients with hepatorenal syndrome with rapid reduction in kidney function.
“Diagnosing and treating hepatorenal syndrome (HRS) can be challenging, and every minute counts when managing patients who have it. Terlivaz gives U.S. physicians the first FDA-approved option for treating HRS patients with rapid reduction in kidney function that may help them improve kidney function and lessen the associated need for renal replacement therapy, such as dialysis,” Steven Romano, MD, executive vice president and chief scientific officer at Mallinckrodt, said in a company press release.
The FDA approval follows the double-blind study of 300 patients with HRS with rapid reduction in kidney function. In the study, 0.85 mg of Terlivaz given every 6 hours for 14 days resulted in an improvement in kidney function. Twenty-nine percent of patients who received the treatment experienced kidney function improvement, compared with 16% of the placebo group.
Risks of the treatment include serious respiratory failure, potential prevention from receiving a liver transplant and ischemic events. Patients with serum creatinine levels of 5 mg/dL or greater should not take the treatment, according to the release.
Terlivaz is the first FDA-approved medication for this condition, according to the FDA press release.
Reference:
- Mallinckrodt receives U.S. FDA approval for Terlivaz (terlipressin) for injection for the treatment of hepatorenal syndrome (HRS).
- https://www.mallinckrodt.com/about/news-and-media/news-detail/?id=29401. Published Sept. 14, 2022. Accessed Sept. 15, 2022.
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