The US Food and Drug Administration (FDA) has approved Mallinckrodt’s Terlivaz (terlipressin) for injection to treat hepatorenal syndrome (HRS).
Terlivaz is claimed to be the first and only FDA-approved product that is indicated for improving kidney function in HRS adult patients with quick kidney function reduction.
The regulatory approval was based on the data obtained from the Phase III CONFIRM trial, which was designed to evaluate terlipressin’s efficacy and safety in HRS type 1 (HRS-1) patients in Canada and the US.
The trial met its primary endpoint of Verified HRS Reversal, which is defined as improvement in renal function, short-term survival, and dialysis avoidance.
Mallinckrodt president and CEO Siggi Olafsson said: “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 U.S. physicians who historically have had limited treatment interventions.
“We’re excited to bring Terlivaz to U.S. 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.”
Abdominal pain, nausea, respiratory failure, diarrhea, and dyspnea are the most common adverse reactions observed in the patients treated with Terlivaz.
In June last year, Mallinckrodt received the US FDA approval for StrataGraft (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen – dsat) for the treatment of thermal burns with intact dermal elements in adults.