Baxter International Inc. (NYSE: BAX), a pioneer in nutrition therapy, proudly announces the United States Food and Drug Administration (FDA) approval of an extended indication for Clinolipid (Lipid Injectable Emulsion), permitting its use in pediatric patients, including preterm and term neonates. Clinolipid, Baxter’s proprietary mixed oil lipid emulsion, is designed to deliver essential calories and fatty acids intravenously when oral or enteral nutrition is not feasible, insufficient, or contraindicated. Initially launched for adult use in 2019, Clinolipid is now approved for patients of all ages.

Cecilia Soriano, President of Baxter’s global Infusion Therapies and Technologies division, commented, “Our dedication to enhancing patient outcomes propels our daily efforts, and we are honored to address the distinctive nutritional necessities of neonatal and pediatric patients through innovative products and therapies. Broadening access to Clinolipid for this crucial and vulnerable patient demographic equips clinicians with versatility in selecting the most suitable product to meet their patients’ needs during critical periods.”

A Distinctive Mixed Lipid Emulsion

Parenteral nutrition stands as a cornerstone in the treatment and mitigation of malnutrition. In the United States, approximately 40 percent of patients who rely on parenteral nutrition for nourishment intravenously are under 18 years old. Intravenous lipid emulsions (ILEs) serve as vital sources of calories and essential fatty acids for patients unable to consume adequate nutrition orally or enterally. In recent years, clinical practice has transitioned from using solely soybean oil lipid emulsions, which were the norm for decades, to mixed lipid emulsions.

Clinolipid, boasting the lowest soybean oil content (20 percent) and the highest olive oil content (80 percent) among mixed ILEs available in the U.S., offers unique characteristics. With over 150 million doses administered worldwide, Clinolipid has demonstrated safety and efficacy as an energy and essential fatty acid source crucial for neonatal and pediatric growth and development. Its notable features include:

• Abundance in omega-9 oleic acid, mirroring human breast milk composition.
• Mitigation of post-natal arachidonic acid level decline.
• Comprehensive stability in parenteral nutrition admixtures.

Baxter’s expanded indication for Clinolipid exemplifies the company’s unwavering commitment to advancing healthcare by addressing the evolving needs of patients across all age groups.