FDA Extends Relizorb’s Approval to Children with Cystic Fibrosis Who Are Fed with a Tube
The U.S. Food and Drug Administration, which approved the device’s use in adults in 2015, has widened the approval to children as young as 5 years old, Alcresta said
The approval is good news for younger cystic fibrosis patients who require supplemental nutrition. Relizorb increases the gut’s absorption of fats, including those crucial for health, such as omega-3.
“This [FDA] clearance represents a significant milestone for children who suffer from fat malabsorption,” Daniel Tassé, Alcresta Therapeutics’ CEO, said in a press release.
“Extending the use of Relizorb into the pediatric population is a significant step forward in addressing the nutritional challenges confronting this critically ill population,” he added.
A study the company conducted showed that blood levels of healthy fats more than doubled when Relizorb was used with tube-feeding formula.
The research, published in the Journal of Pediatric Gastroenterology & Nutrition, was titled “Increased Fat Absorption From Enteral Formula Through an In-line Digestive Cartridge in Patients With Cystic Fibrosis.”
The 33 study participants had received tube-feeding nutrition for an average of 6.6 years. Despite this, their body mass index indicated they were malnourished. Relizorb helped correct this situation.
In addition to increasing fat absorption, its use led to fewer symptoms of fat malabsorption, such as stomach pain, bloating, constipation, and nausea.
The study “demonstrated the efficacy and safety of Relizorb use in correcting deficiencies of healthy fats that are often observed in patients receiving enteral [tube-feeding] nutrition,” said Dr. Eric First, Alcresta’s Chief scientific officer.
Children often have a smaller nutrient reserve, in the form of fat and muscle, than adults, because a lot of the energy they obtain from food is used for growth. This means poor nutrition can have a bigger impact on them — a situation even more exacerbated in children with cystic fibrosis.
The faulty CFTR protein that causes cystic fibrosis leads to malfunctioning of the pancreas, the organ that releases digestive enzymes into the gut. Lipase is a key component of the enzyme mix, breaking down as much as 90 percent of the fat a person consumes. Without it, fat cannot be absorbed and is instead passed as waste.
In addition to malabsorption, high fat content in the gut causes numerous stomach problems.
Relizorb is the only digestive enzyme treatment that can mimic lipase’s normal function, Alcresta says. The cartridge, which is connected to a feeding tube, holds immobilized lipase enzymes. Fats are broken down as the formula passes through the cartridge and comes into contact with the enzymes.
Relizorb can be used in a range of patients with pancreatic insufficiency besides those with cystic fibrosis.