FDA grants fast track designation for MediciNova's MN-001 (tipelukast) for the treatment of idiopathic pulmonary fibrosis

FDA

10 September 2015 - MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market and the JASDAQ Market of the Tokyo Stock Exchange, today announced that it has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for MN-001 (tipelukast) for the treatment of patients with idiopathic pulmonary fibrosis (IPF). 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.

In addition to the granting of Fast Track Designation to MN-001 for treatment of IPF, the FDA granted Orphan Drug Designation to MN-001 for treatment of IPF in October 2014, as previously announced.

Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc., commented, "We are very pleased that MN-001 has received Fast Track Designation for IPF and believe this validates its potential to address unmet medical needs in this life-threatening disease. We look forward to providing further updates as our development program progresses."

For more details, go to: http://investors.medicinova.com/phoenix.zhtml?c=183833&p=irol-newsArticle&ID=2086777

Michael Wonder

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Michael Wonder