Fresenius Kabi launches Omegaven in US for pediatric patients with PNAC
Fresenius Kabi has launched Omegaven (fish oil triglycerides) injectable emulsion in the US, which helps pediatric patients suffering from parenteral nutrition-associated cholestasis (PNAC) with calories and fatty acids.
Omegaven, which is the first and only FDA-approved fish oil lipid emulsion for pediatric patients with PNAC, was previously available in the US for only compassionate use, said the German pharma company.
Cholestasis is a disorder in which the liver does not release bile. PNAC could occur after long-term parenteral nutrition administration in pediatric patients having temporary or permanent intestinal failure.
According to Fresenius Kabi, development of PNAC is related to increased morbidity and mortality and can lead to liver fibrosis, hepatic failure, and even death.
Gordon S. Sacks – senior director, medical affairs for parenteral nutrition at Fresenius Kabi USA said: “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.”
Omegaven is now available across the US as a 5 g/50 mL and 10 g/100 mL (0.1 g/mL) injectable emulsion contained in a single-dose bottle.