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 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," he said. The FDA Orphan Drug designation provides certain incentives to drug companies for medications intended for the treatment, diagnosis or prevention of rare diseases. Earlier this year, results from a Phase 2 clinical trial (NCT02031276) evaluating risankizumab's effectiveness, safety and drug properties showed that the investigational drug was more effective than a placebo in patients with moderate to severely active Crohn’s disease. I
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