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www.fdanews.com/articles/175989-biopharmaceuticals-ubenimex-snags-orphan-drug-designation

BioPharmaceuticals’ Ubenimex Snags Orphan Drug Designation

April 1, 2016

The European Medicines Agency has granted orphan drug designation to Eiger BioPharmaceuticals’ ubenimex for the treatment of pulmonary arterial hypertension.

The oral dual-inhibitor of aminopeptidase and leukotriene A4 hydrolase is approved in Japan as an adjunct to chemotherapy agents. In the U.S. and Europe, ubenimex is not approved for any indication. The compound is currently in Phase 1 trials.