FDA grants orphan drug designation to risankizumab for pediatric Crohn’s disease
The FDA has issued orphan drug designation to AbbVie’s investigational interleukin-23 inhibitor risankizumab for children with Crohn’s disease, the company announced.
Risankizumab (ABBV-066; formerly BI 655066) selectively blocks IL-23, and is currently being evaluated in Crohn’s disease, psoriasis, psoriatic arthritis and asthma, according to a press release. The drug candidate, which is not currently approved, is part of a collaboration between AbbVie and Boehringer Ingelheim, and AbbVie will lead future development and global commercialization.
“This designation reinforces the need for additional treatment options for young people living with this sometimes debilitating disease,” Michael Severino, MD, executive vice president of research and development and chief scientific officer at AbbVie, said in the press release. “Our expertise in immunology provides a unique perspective and we look forward to continuing to evaluate risankizumab as a potential new therapy for patients.”
The FDA issues orphan designation to drugs that treat rare diseases or disorders that affect fewer than 200,000 Americans, or for those that are not expected to recover development and marketing costs.
Disclosures: Severino is employed by AbbVie.