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news.Eiger BioPharmaceuticals has secured orphan medicinal product designation from the European Medicines Agency (EMA) for ubenimex to treat pulmonary arterial hypertension (PAH).
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Ubenimex is an oral, small-molecule, dual-inhibitor of aminopeptidase and leukotriene A4 hydrolase (LTA4H), the enzyme which catalyzes the committed step in the formation of the pro-inflammatory mediator, LTB4.
The benefits of orphan drug status in the European Union include a 10-year period of market exclusivity for the indication, if approved.
Eiger BioPharmaceuticals chief medical officer Joanne Quan said: "We will soon begin enrolling the LIBERTY study, a Phase 2, randomized, double-blind, placebo-controlled, multi-center study of ubenimex in PAH patients."
Ubenimex is approved in Japan as an adjunct to chemotherapy agents to extend survival and to maintain remission following the treatment for acute non-lymphocytic leukemia in adults.
The drug has been used for more than 25 years in Japan and remains commercially available via Nippon Kayaku under the brand name, Bestatin.
Ubenimex is not approved for any indication in the US or Europe. Last November, ubenimex secured orphan drug designation for PAH in the US.
PAH is a type of high blood pressure that affects the arteries in the lungs and the right side of the heart.
It starts when tiny arteries in the lungs, dubbed pulmonary arterioles, become narrowed, blocked or destroyed.