Fresenius Kabi launches Omegaven for pediatric patients with parenteral nutrition-associated cholestasis in US

Fresenius Kabi, a prominent German pharmaceutical company, has introduced Omegaven (fish oil triglycerides) injectable emulsion in the United States, targeting a critical need for pediatric patients suffering from parenteral nutrition-associated cholestasis (PNAC). This launch marks Omegaven as the first and only FDA-approved fish oil lipid emulsion specifically designed for children with PNAC, expanding its availability beyond its prior status as a compassionate use product.

Omegaven’s Role in Managing PNAC

Parenteral nutrition-associated cholestasis is a liver disorder that can arise from prolonged parenteral nutrition in children with temporary or permanent intestinal failure. In PNAC, the liver fails to release bile, leading to a range of serious complications. According to Fresenius Kabi, the development of PNAC is linked to increased morbidity and mortality, potentially resulting in liver fibrosis, hepatic failure, and even death.

The launch of Omegaven addresses a significant gap in the treatment landscape for these vulnerable patients. Gordon S. Sacks, Senior Director of Medical Affairs for Parenteral Nutrition at Fresenius Kabi USA, emphasized the critical need for such a solution: “Omegaven fills a critical gap in the current nutrition management of pediatric patients suffering from PNAC. Previously, clinicians had no options for the provision of lipids for these vulnerable children, who because of PNAC, are at serious risk of liver failure. Fresenius Kabi is pleased Omegaven is now widely available to meet the short and long-term calorie and fatty acid needs of PNAC pediatric patients that were previously unmet.”

Product Availability

Omegaven is now accessible throughout the US in two formulations: a 5 g/50 mL and a 10 g/100 mL injectable emulsion, each containing 0.1 g/mL of fish oil triglycerides. The emulsion is supplied in single-dose bottles, facilitating its use in clinical settings.

This development represents a significant advancement in the management of PNAC, providing a crucial option for pediatric patients who previously had limited alternatives. With Omegaven now available, Fresenius Kabi aims to improve outcomes and support the nutritional needs of children affected by this challenging condition.