Alcresta Therapeutics, a leading commercial-stage company focused on developing and commercializing novel enzyme-based products, today announced that the U.S. Food and Drug Administration (FDA) has cleared expanded use of RELiZORB to children ages 2 to <5 years.
RELiZORB is a digestive enzyme cartridge designed to mimic the function of pancreatic lipase that was first FDA-cleared in 2015 for use in adult patients and was cleared in 2017 for use in children as young as five years old. RELiZORB is the only enzyme product cleared by the FDA for use with enteral feeding.
The clearance for ages 2 to <5 years is based on a retrospective evaluation of real-world data in patients 2 to <5 years old who received enteral formula administered through RELiZORB as part of an enteral feeding regimen. No additional safety concerns were identified with RELiZORB use in this patient population.
“This additional RELiZORB clearance represents access for approximately 25% of the cystic fibrosis enterally fed market and for enterally fed pediatric patients ages 2 to <5 years suffering from conditions that contribute to fat malabsorption,” stated Dan Orlando, Chief Executive Officer at Alcresta Therapeutics. “Adequate nutrition for children is critical to growth and development. Enterally fed children living with rare diseases and experiencing fat malabsorption can be highly susceptible to the effects of poor nutrition and nutritional support is vital to maintaining growth and development.”
About RELiZORB CARTRIDGE
RELiZORB is a first-of-its kind digestive enzyme cartridge designed to mimic the function of pancreatic lipase. RELiZORB is developed using Alcresta’s proprietary enzyme immobilization technology, iLipase, which is the digestive enzyme lipase bound to small polymeric bead carriers. RELiZORB connects in-line to enteral feeding systems. As enteral formula passes through RELiZORB, it makes contact with the iLipase and the fat in the formula is broken down into an absorbable form prior to ingestion.
Individuals experiencing fat malabsorption requiring enteral nutrition cannot effectively hydrolyze (break down) fats from nutrition into a form that the body can absorb. Fat malabsorption is common in individuals who cannot produce adequate amounts of digestive enzymes because of compromised pancreatic function resulting in exocrine pancreatic insufficiency (EPI).
Enteral formulas do not contain pre-hydrolyzed fats because they are unstable and spoil quickly. Incomplete hydrolysis of fats from enteral nutrition can lead to decreased caloric intake and reduced digestion of essential fats, which can significantly impact quality of life and nutritional status. Children are most vulnerable to the consequences of untreated pancreatic insufficiency.
