MediciNova, Inc., announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to MN-166 (ibudilast) for treatment of Type 1 - Early Infantile Krabbe disease.
Under the FDA's rare pediatric disease priority review voucher program, the sponsor may be eligible for a voucher that can be used to obtain a priority review for a subsequent human drug application. The FDA has previously granted orphan drug designation to MN-166 (ibudilast) for treatment of Krabbe disease.
Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc., commented, "We are very pleased to receive Rare Pediatric Disease Designation for MN-166 for treatment of Krabbe Disease.
There is an unmet medical need for treatment of Krabbe disease in the pediatric population and we plan to work closely with the FDA and clinical experts to evaluate MN-166 in the pediatric population.”
