#United States #FDA Approval #Waltham #RELiZORB #Alcresta

Alcresta Therapeutics Announces Expanded FDA Clearance for RELiZORB®

In a significant advancement for pediatric healthcare, Alcresta Therapeutics, Inc. proclaimed the recent clearance by the U.S. Food and Drug Administration (FDA) for the expanded use of its RELiZORB® (iMMOBILIZED LIPASE) cartridge targeting children aged one year and older. Originally designed as a digestive enzyme cartridge that simulates pancreatic lipase, RELiZORB is an innovative solution that helps children with dietary fat absorption issues.

Overview of RELiZORB®

RELiZORB allows healthcare providers to offer more versatile nutritional support to younger patients, specifically those suffering from fat malabsorption conditions. This FDA expansion is based on a thorough retrospective evaluation showcasing the product's effectiveness among children aged between one to two years. Notably, there were no new safety concerns identified within this age group, leading to this positive regulatory decision.

Dan Orlando, CEO of Alcresta Therapeutics, emphasized the impact of this clearance, stating, "Achieving approval for children aged one and above marks a crucial milestone for RELiZORB and is particularly beneficial for enterally fed patients grappling with fat malabsorption issues. This approval not only expands access for patients reliant on enteral nutrition but aligns with essential growth needs for children facing health challenges."

With its commercial launch occurring in May 2024, the next-generation RELiZORB cartridge has evolved to accommodate a growing patient demographic, including those with short bowel syndrome (SBS). The unique design enables it to attach directly to enteral feeding systems. As formula passes through RELiZORB, the immobilized lipase effectively breaks down the fats, promoting better nutrient absorption before ingestion.

Historical Context

Initially approved for adult use in 2015, the RELiZORB cartridge has been progressively made available for pediatric patients, having expanded its indications to include children as young as five in 2017, and later two years old in August 2023. This most recent FDA action allows usage for younger patients, thus legally paving the way for infants and toddlers who require enteral feeding solutions.

As reported, the innovative manufacturing process of RELiZORB leverages Alcresta's proprietary enzyme immobilization technology known as iLipase®, which enhances the reliability and effectiveness of fat digestion for enterally-fed patients with pancreatic insufficiency, a common issue in individuals with cystic fibrosis, pancreatic cancer, and pancreatitis.

Alcresta Therapeutics, Inc.

Dedicated to addressing the unique needs of patients with gastrointestinal disorders and rare diseases, Alcresta Therapeutics is committed to optimizing nutrition through enzyme technology. The company is also exploring avenues for a platform application tailored for premature infants in NICU environments. Their continued dedication to innovation and support for those with specific medical needs highlights their integral role within the healthcare industry.

For further information on Alcresta Therapeutics and RELiZORB, interested parties can visit their official website.

This FDA validation represents a beacon of hope for many, highlighting Alcresta’s commitment to improving healthcare outcomes for vulnerable populations, particularly children who rely on enteral nutrition. With a focus on expanding access and meeting various nutritional needs, Alcresta’s initiatives underscore the importance of personalized patient care in modern medicine.