FDA Grants Orphan Drug Status to AbbVie’s Therapy for Pediatric Crohn’s Disease

FDA Grants Orphan Drug Status to AbbVie’s Therapy for Pediatric Crohn’s Disease
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to AbbVie’s investigational drug risankizumab for the treatment of pediatric patients with Crohn's disease. Risankizumab (ABBV-066) selectively blocks IL-23, a key protein involved in inflammatory processes that have been linked to a number of chronic immune-mediated diseases. Risankizumab is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading the drug's development and commercialization worldwide. The therapeutic potential of risankizumab is being evaluated in immunological disorders, including Crohn’s disease, psoriasis, and psoriatic arthritis. "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," Michael Severino, MD, AbbVie's executive vice president of research and development and chief scientific officer, said in a press release. "This designation reinforces the need for additional treatment options for young people living with this sometimes debilita
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