Alcresta Therapeutics Announces FDA Expanded Use Clearance for RELiZORB® (iMMOBILIZED LIPASE) Cartridge for Pediatric Patients 1 Year of Age and Older

WALTHAM, Mass., Jan. 15, 2025 /PRNewswire/ -- Alcresta Therapeutics, Inc., 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^® for children down to age 1 year old. RELiZORB is a digestive enzyme cartridge designed to mimic the function of pancreatic lipase.

The expanded indication for ages 1 and above is based on a retrospective evaluation of real-world data in patients aged 1 to 2 years old who utilized RELiZORB in enteral formula as part of their nutrition routine. No additional safety concerns were identified with RELiZORB use in this younger patient population.

"Receiving clearance for children ages 1 and above signifies another meaningful milestone for RELiZORB and enterally fed patients with fat malabsorption," said Dan Orlando, Chief Executive Officer at Alcresta Therapeutics. "Since its commercial availability in May 2024, our second-generation cartridge has expanded use, specifically to patients with short bowel syndrome (SBS), helping address the essential nutritional needs for these patients and many other patients living with rare diseases. We are excited that the expansion of RELiZORB's indication will help to further expand access, especially in younger populations where nutritional goals associated with growth and development are vitally important."

About RELiZORB^® (iMMOBILIZED LIPASE) CARTRIDGE 

RELiZORB is indicated for use in pediatric patients (ages 1 year and above) and adult patients to hydrolyze fats in enteral formula. 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, the bound lipase breaks down formula fats into an absorbable form prior to ingestion. RELiZORB was FDA-cleared in 2015 for use in adult patients and was cleared in 2017 for use in children as young as five years old. Use was expanded to pediatric patients as young as two years old in August 2023. The next-generation RELiZORB device was introduced to market in May 2024 with broader formula compatibility, an increase in the number of devices used per day and use in both continuous and bolus-feeding set ups.

About Alcresta Therapeutics, Inc. 

Alcresta Therapeutics, Inc. is dedicated to developing and commercializing novel, enzyme-based products designed to address challenges faced by patients living with gastrointestinal disorders and rare diseases. Alcresta currently markets RELiZORB for enterally-fed patients with pancreatic insufficiency, which occurs in cystic fibrosis, pancreatic cancer, and pancreatitis, and short bowel syndrome, which is marked by significant malabsorption due to limited absorptive area as a result of resection. Alcresta is currently developing a platform application for prematurely born infants treated in the NICU. Alcresta Therapeutics, Inc. is backed by Linden Capital Partners and HealthQuest Capital. More information can be found at www.alcresta.com. 

Internal Media Contact:

Natalie Bronfin
Alcresta Therapeutics, Inc.
[email protected]
617-431-3600

SOURCE Alcresta Therapeutics, Inc.