Alcresta Therapeutics announced that the Food and Drug Administration (FDA) has granted clearance for its RELiZORB (immobilized lipase) digestive enzyme cartridge for use in pediatric patients aged ≥5 years with fat malabsorption.

In 2015, RELiZORB was initially approved for use in patients aged ≥18 years. The expanded pediatric indication was supported by data from the multicenter, randomized, double-blind, crossover 497 Study (n=33). In the study, authors measured plasma omega-3 fatty acid concentrations as markers of fat absorption. Safety and tolerability were assessed by documentation of gastrointestinal (GI) symptoms. 

Use of RELiZORB led to a statistically significant 2.8-fold increase in plasma omega-3 fatty acid concentrations. The researchers also noted an increase in appetite preservation and breakfast consumption in patients using RELiZORB. 

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“The 497 Study demonstrated the efficacy and safety of RELiZORB use in correcting deficiencies of healthy fats that are often observed in patients receiving enteral nutrition,” said Eric First, MD, Chief Scientific Officer, Alcresta Therapeutics. 

RELiZORB is a a first-of-its kind external digestive enzyme therapy that works by mimicking the normal pancreatic function of lipase, an essential enzyme in the digestion of dietary fats. RELiZORB significantly increases fat absorption by breaking down fats contained in enteral nutrition formulas. This results in increased availability of calories and important healthy fats that may otherwise go unabsorbed. 

RELiZORB is available as single-use cartridges.

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