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14 Sep 2015

FDA grants Fast Track status for MediciNova’s MN-001

MediciNova, Inc., a biopharmaceutical company, has received Fast Track designation from the US 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 programme 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.

According to the FDA, in order to be granted Fast Track designation, a drug must (1) be intended for the treatment of a serious or life-threatening disease or condition; and (2) demonstrate the potential to address unmet medical needs for the disease or condition. A drug that receives Fast Track designation may be eligible for more frequent meetings with the FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval; accelerated approval, i.e., approval based on an effect on a surrogate, or substitute endpoint reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality; Priority Review, with an FDA goal for completing review within six months of submission; and Rolling Review, which means that a sponsor can submit completed sections of its New Drug Application (NDA) for review by the FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed.

 

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