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Alcresta Therapeutics Granted FDA Clearance to Expand RELiZORB® (iMMOBILIZED LIPASE) Cartridge Usage for Children Ages 2 to 5 Years

Friday, September 01, 2023

Alcresta Therapeutics, a leading commercial-stage company specializing in the development and distribution of novel enzyme-based products, has announced that the U.S. Food and Drug Administration (FDA) has expanded the use of RELiZORB® to include children aged 2 to <5 years. RELiZORB is a unique digestive enzyme cartridge designed to replicate the function of pancreatic lipase. Initially cleared by the FDA in 2015 for adult patients and in 2017 for children as young as five years old, RELiZORB is the sole enzyme product approved for enteral feeding by the FDA.

The clearance for children aged 2 to <5 years was based on a retrospective analysis of real-world data from patients in this age group who received enteral formula through RELiZORB as part of their enteral feeding regimen. No additional safety concerns were identified in the use of RELiZORB in this specific patient population.

Dan Orlando, Chief Executive Officer at Alcresta Therapeutics, emphasized the significance of this expanded clearance, noting that it would provide access to approximately 25% of the cystic fibrosis enterally fed market and benefit pediatric patients aged 2 to <5 years who suffer from conditions contributing to fat malabsorption. Orlando stressed the critical role of adequate nutrition in the growth and development of children, particularly those reliant on enteral feeding due to rare diseases and fat malabsorption.

RELiZORB is a groundbreaking digestive enzyme cartridge designed to emulate the function of pancreatic lipase. Alcresta has developed RELiZORB using its proprietary enzyme immobilization technology, iLipase®, which binds the digestive enzyme lipase to small polymeric bead carriers. RELiZORB can be integrated in-line with enteral feeding systems. As enteral formula passes through RELiZORB, it comes into contact with iLipase, breaking down the fat in the formula into an absorbable form before ingestion.

Individuals experiencing fat malabsorption and requiring enteral nutrition often struggle to effectively break down fats from their nutrition into an absorbable form. This condition is prevalent among individuals with compromised pancreatic function, leading to exocrine pancreatic insufficiency (EPI) and an insufficient production of digestive enzymes. Enteral formulas do not contain pre-hydrolyzed fats because they are unstable and spoil quickly. Insufficient fat hydrolysis from enteral nutrition can result in reduced caloric intake and impaired digestion of essential fats, significantly impacting overall quality of life and nutritional status. Children are especially vulnerable to the consequences of untreated pancreatic insufficiency.

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