Risankizumab granted Orphan Drug Designation by FDA

AbbVie's risankizumab has been granted Orphan Drug Designation by the U.S. Food and Drug Administration for the investigational treatment of pediatric patients who have Crohn’s disease.
"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," AbbVie Executive Vice President of Research Dr. Michael Severino said. "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."
Risankizumab is being assessed for the treatment of immunological disorders such as Crohn’s disease, psoriasis, psoriatic arthritis and asthma. Risankizumab is the results of a partnership between Boehringer Ingelheim and AbbVie, with AbbVie handling the development and commercialization of the drug on a worldwide scale.
The drug has yet to be approved by regulatory authorities.