Medicinova's (MNOV) MN-166 Granted FDA Orphan Drug Designation as ALS Treatment

October 12, 2016 6:14 AM EDT
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MediciNova, Inc., (Nasdaq: MNOV), announced that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation to MN-166 (ibudilast) for treatment of Amyotrophic Lateral Sclerosis (ALS).

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 (CHS) 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 (ibudilast) for ALS."

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