FDA Awards Eiger’s Ubenimex Orphan Drug Designation for PAH

The FDA has awarded orphan drug designation to Eiger BioPharmaceuticals’s ubenimex for the treatment of pulmonary arterial hypertension.

An oral, small molecule, ubenimex is a dual-inhibitor of aminopeptidase and leukotriene A4 hydrolase.  It is approved in Japan as an adjunct to chemotherapy for acute non-lymphocytic leukemia and is branded as Bestatin.