Children as young as 2 now may use digestion aid Relizorb

The FDA expands use of enzyme cartridge that connects to enteral feeding tube

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by Steve Bryson, PhD |

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The U.S. Food and Drug Administration (FDA) will allow children with cystic fibrosis (CF) as young as age 2 to use Relizorb, an enzyme cartridge that connects with an enteral feeding tube to provide easier digestion of fats.

“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 [less than] 5 years suffering from conditions that contribute to fat malabsorption,” Dan Orlando, CEO of Alcresta Therapeutics, which markets Relizorb, said in a press release.

The characteristic mucus buildup in people with CF can affect the pancreas, blocking the release of digestive enzymes needed to break down nutrients, particularly fats. This leads to exocrine pancreatic insufficiency (EPI), a condition that affects patients’ weight and growth.

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When patients struggle to maintain or gain weight, an enteral feeding tube can help provide the necessary nutrients, pumped directly into the stomach or intestine via flexible tubes.

“Adequate nutrition for children is critical to growth and development,” Orlando noted. “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.”

Relizorb is a first-of-its-kind digestive enzyme cartridge that mimics the function of pancreatic lipase, an enzyme that breaks down dietary fats and allows them to be absorbed. Immobilized on beads fixed to the end of a feeding tube, the enzyme (iLipase, Alcresta’s proprietary enzyme immobilization technology) breaks down fats in the feeding formula. The iLipase remains in the cartridge and is not ingested, even over long feeding sessions.

Incremental approvals of Relizorb

Relizorb was first cleared by the FDA for adults in 2015 and then approved in 2017 for CF patients ages 5 and older who require supplemental nutrition.

ASSURE (NCT02750501), an Alcresta-sponsored clinical trial, demonstrated that Relizorb improves the absorption of fats, particularly omega-3 fatty acids, in tube-fed CF patients. Additionally, data from a year-long observational study showed that Relizorb improved weight and height significantly among CF patients with EPI who required feeding.

FDA clearance for CF children ages 2 to 5 was based on a review of real-world data in which Relizorb was used as part of an enteral feeding regimen for this patient population. According to Alcresta, no additional safety concerns were reported in these patients.

In 2021, the Centers for Medicare and Medicaid Services (CMS) announced that Relizorb will be covered by Medicare.