Baxter's Clinolipid wins FDA OK; addresses drug shortage
This article was originally published in Scrip
Baxter won the US FDA's approval on 4 October to market its parenteral nutrition product Clinolipid (lipid injectable emulsion), which is intended for use in adults unable to eat or drink to provide a source of calories and essential fatty acids.
Concerned over the short supply of injectable lipid emulsion products, regulators granted Clinolipid a priority review to help alleviate a drug shortage, said Dr Donna Griebel, director of the FDA's Division of Gastroenterology and Inborn Errors Products.Dr Janet Woodcock, director of the agency's Center for Drug Evaluation and Research, insisted preventing and mitigating drug shortages is a "top priority for the FDA.”
Clinolipid is a lipid emulsion that contains a mixture of refined olive oil and refined soybean oil.
Regulators said the fatty acids contained in Clinolipid serve as an important source of energy in patients receiving parenteral nutrition.
But the agency emphasized that the omega-3: omega-6 fatty acid ratio in Clinolipid has not been shown to improve clinical outcomes compared to other lipid emulsion products.
Like other intravenous lipid emulsions, the FDA said Clinolipid should be used with caution in patients with preexisting liver disease or liver insufficiency.
The product is not intended for use in patients with a known hypersensitivity to egg or soybean proteins, or in those with hyperlipidemia, the FDA said.
It also is not indicated for use in preterm infants, with the product's labeling specifically warning about the risk of death in those patients after infusion of intravenous lipid emulsions.
Clinolipid also is not indicated for use in other pediatric patients because it is not known whether the amount of essential fatty acids found in the drug is enough to meet the nutritional needs of children, regulators said.
The safety and effectiveness of Clinolipid were evaluated in clinical studies comparing the drug with a soybean oil-based lipid emulsion.
The most common side effects in patients treated with Clinolipid in clinical testing includes infectious complications, nausea and vomiting, excess lipids in the blood, high blood sugar, low levels of protein in the blood and abnormal liver function tests.