Risankizumab is being evaluated in immunological disorders, including Crohn's disease, psoriasis, psoriatic arthritis and asthma.
Risankizumab is an investigational treatment that is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading future development and commercialization of risankizumab globally. Risankizumab is not currently approved by regulatory authorities.
AbbVie executive vice president of research and development and chief scientific officer Michael Severino said: "AbbVie is committed to providing innovative treatment options to patients, particularly in areas with unmet medical needs such as Crohn's disease in children – a disease that may impact physical and social development.
"This designation reinforces the need for additional treatment options for young people living with this sometimes debilitating disease. Our expertise in immunology provides a unique perspective and we look forward to continuing to evaluate risankizumab as a potential new therapy for patients."
Crohn's disease is a type of inflammatory bowel disease which commonly involves the end of the small intestine and the large intestine.
Children living with Crohn's disease may be affected by a delay in growth and sexual maturation, and may experience symptoms similar to those in adults including diarrhea, abdominal pain, rectal bleeding and weight loss.
The FDA Orphan Drug Designation is granted to medicines and biologics that are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States, or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment medicine.