FDA expands immobilized lipase cartridge clearance down to 1 year
The digestive enzyme cartridge is designed to mimic pancreatic lipase function.
FDA expands immobilized lipase cartridge approval down to 1 year old | Image Credit: © Araki Illustrations - © Araki Illustrations - stock.adobe.com.
Immobilized lipase cartridge (Relizorb; Alcresta Therapeutics) can now be used in children down to 1 year of age, following an expanded clearance by the FDA, according to a recent announcement from Alcresta.1
The first-of-its-kind digestive enzyme cartridge is designed to mimic the function of pancreatic lipase, and is cleared to hydrolyze fats in enteral formula.
"[Immobilized lipase cartridge] connects in-line to enteral feeding systems," stated Alcresta. "As enteral formula passes through immobilized lipase cartridge, the bound lipase breaks down formula fats into an absorbable form prior to ingestion."
The expanded indication cleared by the FDA is based on a retrospective evaluation of real-world data in patients aged 1 to 2 years who used immobilized lipase cartridge in enteral formula as a part of their nutrition routine. In this younger population, no additional safety concerns were identified with immobilized lipase cartridge use.
“Receiving clearance for children ages 1 and above signifies another meaningful milestone for [immobilized lipase cartridge] and enterally fed patients with fat malabsorption,” said Dan Orlando, Chief Executive Officer at Alcresta Therapeutics, in a statement.
"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 [immobilized lipase cartridge]'s indication will help to further expand access, especially in younger populations where nutritional goals associated with growth and development are vitally important," said Orlando.
Initially, immobilized lipase cartridge was FDA-cleared in 2015 for use in adult patients, followed by an expanded use clearance for children as young as 5 years in 2017. In August of 2023, use was cleared for patients aged 2 years and up.
Reference:
Alcreasta Therapeutics announces FDA expanded use clearance for Relizorb (immobilized lipase) cartridge for pediatric patients 1 year of age and older. Alcresta Therapeutics. Press release. January 15, 2025. Accessed January 16, 2025. https://www.biospace.com/press-releases/alcresta-therapeutics-announces-fda-expanded-use-clearance-for-relizorb-immobilized-lipase-cartridge-for-pediatric-patients-1-year-of-age-and-older
