Eiger BioPharmaceuticals announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to ubenimex for the treatment of pulmonary arterial hypertension (PAH).
Ubenimex has been used in Japan for over 25 years and is approved as an adjunct to chemotherapy to extend survival and to maintain remission after treatment for acute non-lymphocytic leukemia in adults. It is not approved for any indication in the U.S. or Europe.
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Ubenimex is an oral, small-molecule, aminopeptidase and leukotriene A4 hydrolase (LTA4H) dual inhibitor.
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