FDA grants fast track designation for MedicNova's MN-166 MediciNova and the Jasdaq Market of the Osaka Securities Exchange (Code Number: 4875), announced that it has received Fast Track designation from the U.S. FDA for MN-166 (ibudilast) for the treatment of methamphetamine dependence. Fast Track is a process designed to facilitate the development and expedite the review of drugs that are intended to treat serious diseases and have the potential to fill an unmet medical need. An important feature of the FDA's Fast Track program is that it emphasizes early and 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.
MediciNova announces FDA approval of second Phase 2 protocol for MN-001 in NASH MediciNova announced that FDA has approved a second protocol for a clinical trial evaluating MN-001 for a NASH indication. This study targets NASH patients with hypertriglyceridemia to evaluate the ability of MN-001 to improve cardiovascular risk by assessing cholesterol-efflux capacity and serum triglyceride levels as well as reduction of percent fat in the liver, as assessed by MRI.