US FDA Approves Alcresta's RELiZORB for Children Aged 1

Alcresta Therapeutics, Inc., a prominent company in the commercial stage that specializes in creating and marketing innovative enzyme-based products, announced that the US Food and Drug Administration (FDA) has approved the expanded utilization of RELiZORB for children down to age 1 year old. RELiZORB is a digestive enzyme cartridge created to replicate the role of pancreatic lipase.

The broadened indication for individuals aged 1 and older is grounded in a retrospective assessment of real-world data from patients aged 1 to 2 years who used RELiZORB in enteral formula as a component of their nutritional regimen. No new safety issues were recognized with the use of RELiZORB in this younger patient group.

“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.”