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AbbVie get Orphan Drug Designation for Risankizumab from U.S.FDA

 

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AbbVie , a global biopharmaceutical company,  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. 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.

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