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MediciNova Announces FDA Approval of Protocol for Phase 2 Trial of MN-001 in IPF
GlobeNewswire - Tue Feb 10, 8:07AM CST
MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (Nasdaq:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that FDA (U.S. Food and Drug Administration) has approved the protocol for a clinical trial of MN-001 (tipelukast) for the treatment of moderate to severe IPF (idiopathic pulmonary fibrosis). Importantly, due to safety data from previous clinical studies of MN-001, FDA has agreed that MediciNova may proceed with a Phase 2 study as the first clinical trial of MN-001 in IPF. The IPF protocol was filed under MediciNova's open IND (Investigational New Drug Application) in FDA's Division of Pulmonary, Allergy, and Rheumatology Products (DPARP). FDA has granted orphan-drug designation to MN-001 for the treatment of IPF, which will provide MediciNova with seven years of marketing exclusivity if MN-001 is approved for IPF.
MNOV: 3.62 (-0.56)
MediciNova awarded Notice of Allowance for MN-001 and MN-002 for NASH from US Patent and Trademark Office
M2 - Wed Feb 04, 5:23AM CST
Biopharmaceutical company