U.S. Food and Drug Administration Gives AbbVie the Orphan Drug Designation for Investigational IL-23 Inhibitor Risankizumab for Treating Pediatric Patients with Crohn’s Disease

abbvie

Nov 30, 2016

AbbVie, a global biopharmaceutical company, has 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 pediatric patients with Crohn’s disease. It is a special type of inflammatory bowel disease which commonly involves the end of the small intestine and the large intestine.

Risankizumab is being evaluated in immunological disorders, including Crohn’s disease, asthma, psoriasis, and psoriatic arthritis. Risankizumab is an investigational treatment that is part of a collaboration between AbbVie and Boehringer Ingelheim, with AbbVie leading commercialization and future development of risankizumab globally.

Michael Severino, M.D., executive vice president of research and development and chief scientific officer, AbbVie, 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.”

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