ProMetic Life Sciences Inc.'s treatment for a form of bowel disease secured the U.S. Food and Drug Administration's rare pediatric disease designation.
ProMetic's inter-alpha-inhibitor-proteins secured the designations for the treatment of necrotizing enterocolitis — a disease where a portion of the bowel dies.
Necrotizing enterocolitis is the most common acquired gastrointestinal disease affecting premature infants. It is characterized by damage to the intestinal wall, leading to perforation of the intestine and spilled stool into the infant's abdomen.
The Canadian biopharmaceutical company secured an orphan drug designation for the treatment earlier in February.
The rare pediatric disease designation is granted to drugs that have the potential to treat orphan diseases affecting fewer than 200,000 patients in the U.S. and with more than 50% of those affected age 18 years or younger.
