MediciNova's MN-166 Granted Fast Track Designation by FDA

MediciNova, Inc. (NASDAQ:MNOV) has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the development of MN-166 (ibudilast) for the treatment of patients with progressive multiple sclerosis (progressive MS).
According to the news:

Progressive MS includes both primary progressive MS (PPMS) and secondary progressive MS (SPMS).  Fast Track is a process designed to facilitate the development and expedite the review of drugs that are intended to treat serious or life-threatening diseases and demonstrate the potential to address unmet medical needs for such diseases.  An important feature of the FDA’s Fast Track program is that it emphasizes frequent communication between the FDA and the sponsor throughout the entire drug development and review process to improve the efficiency of product development. Accordingly, Fast Track status can potentially lead to a shortened timeline to ultimate drug approval.

Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc., commented:

We are very pleased that MN-166 has received Fast Track Designation for progressive MS and believe this validates its potential to address unmet medical needs for this serious disease.  We look forward to providing further updates from our ongoing clinical trial in progressive MS.

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