FDA Blesses Alcresta’s Digestive Enzyme Cartridge
Newton, Mass.-based Alcresta Pharmaceuticals has won de novo approval from the FDA to market its Relizorb (immobilized lipase), a digestive enzyme cartridge designed to emulate the pancreatic function by breaking down fats in enteral tube feeding formula.
The device’s process enables the delivery of increased absorbable calories from fatty acids and monoglycerides to adults who are unable to break down and absorb fats.
Compromised pancreatic function is the most common cause of fat malabsorption, as these individuals cannot produce sufficient quantities of digestive enzymes.
Alcresta is a specialty pharmaceutical company focused on developing enzyme-based products to treat people living with gastrointestinal disorders and rare diseases. — Michael Cipriano