Alcresta Therapeutics Inc, a US-based commercial-stage company focused on developing and commercialising novel enzyme-based products, announced on Wednesday that it has received approval from the US Food and Drug Administration (FDA) for the expanded use of RELiZORB for children as young as 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 assessment of real-world data in patients aged 1 to 2 years old who used RELiZORB in enteral formula as part of their nutrition routine. No additional safety concerns were seen with RELiZORB use in this younger patient population.

Dan Orlando, Alcresta Therapeutics' CEO, said: "Receiving clearance for children ages 1 and above signifies another meaningful milestone for RELiZORB and enterally fed patients with fat malabsorption. 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."