- Orphan Drug Designation program provides orphan status to medications intended for the safe and effective treatment, diagnosis or prevention of rare diseases[1]
- Risankizumab is an investigational treatment being evaluated in immunological disorders, including Crohn's disease, psoriasis, psoriatic arthritis and asthma, that selectively blocks interleukin-23 (IL-23) – a key signaling agent that has been linked to a number of chronic immune-mediated diseases
- Crohn's disease is an incurable chronic, inflammatory condition of the gastrointestinal tract that can cause diarrhea, abdominal pain and weight loss[2]
NORTH CHICAGO, Ill., Nov. 30, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to risankizumab (ABBV-066; formerly BI 655066) for the investigational treatment of Crohn's disease in pediatric patients.
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 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,"3 said Michael Severino, M.D., executive vice president of research and development and chief scientific officer, AbbVie. "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.2 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.2-4
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.1
