MediciNova says FDA grants orphan drug designation to ALS treatment
MediciNova announced that the U.S. Food and Drug Administration has granted orphan-drug designation to MN-166 for treatment of Amyotrophic Lateral Sclerosis. Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc., commented, "We are very pleased to receive orphan-drug designation for MN-166 for ALS, a rare disease for which riluzole is the only currently approved treatment option. Currently we have two ongoing clinical trials to evaluate MN-166 in ALS in collaboration with researchers at Carolinas HealthCare System's Neuromuscular/ALS-MDA Center and Massachusetts General Hospital. MN-166 demonstrated positive trends in the interim efficacy data from the mid-study analysis of the CHS Neuromuscular/ALS-MDA Center study. This interim data was submitted to FDA to address the scientific rationale for orphan-drug designation to establish the medical basis for the use of MN-166 for ALS."