Mallinckrodt plc on Friday announced that the US Food and Drug Administration (FDA) approved Terlivaz (terlipressin) for injection. According to the company, terlivaz is the first and only FDA-approved product indicated to improve kidney function in adults with hepatorenal syndrome (HRS) with a rapid reduction in kidney function, an acute and life-threatening condition requiring hospitalization.
“The FDA approval of Terlivaz is a significant milestone for Mallinckrodt as it brings an important treatment option to these critically ill patients requiring hospitalization and to US physicians who historically have had limited treatment interventions. We’re excited to bring Terlivaz to US patients and physicians and plan to launch the product in the coming weeks. This approval reflects Mallinckrodt’s continued commitment to underserved patients and their caregivers through our demonstrated expertise and dedication to developing therapeutics for critical conditions,” Siggi Olafsson, president and chief executive officer, said in a statement.
The company claims that Terlipressin is recommended by the American Association for the Study of Liver Diseases (AASLD) guidance and the American College of Gastroenterology (ACG) guidelines.
“Terlipressin is one of the most studied pharmacological agents in HRS with more than 70 published manuscripts and presented abstracts on clinical data to date. It has been approved outside the US for more than 30 years and is available on five continents for its indications in the countries where it is approved,” the company stated on Friday.
The company also announced that the FDA approval was based, in part, on results from the phase 3 CONFIRM trial, the largest-ever prospective study (n=300) conducted to assess the safety and efficacy of terlipressin in patients with HRS type 1 (HRS-1) in the US and Canada.
“Diagnosing and treating HRS can be challenging, and every minute counts when managing patients who have it. Terlivaz gives US physicians the first FDA-approved option for treating HRS patients with rapid reduction in kidney function1 that may help them improve kidney function and lessen the associated need for renal replacement therapy, such as dialysis,” Steven Romano, M.D., executive vice president and chief scientific officer at Mallinckrodt stated on Monday.
Reportedly, Terlivaz is expected to be available in the US in the coming weeks.
Hepatorenal syndrome (HRS) is an acute and life-threatening condition that involves a rapid reduction in kidney function and occurs in people with advanced liver disease.